Panels › Anesthesiology › Product code BTY · Class 2
Calculator, Predicted Values, Pulmonary Function
Regulation 868.1890
1510(k)s in 12 months (64 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in BTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Viasys Healthcare GmbH | 5 | 0 |
| Erich Jaeger B.V. | 4 | 0 |
| Medical Graphics Corp. | 4 | 0 |
| Shape Medical Systems, Inc. | 2 | 2 |
| Carefusion Germany 234 GmbH | 3 | 0 |
| Cosmed Srl | 3 | 0 |
| Eresearchtechnology GmbH | 3 | 0 |
| Medical Associated Services, Inc. | 3 | 0 |
| Ndd Medizitechnik AG | 2 | 0 |
| NDDd Medical Technologies, Inc. | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K260242 | CPETWise Platform Medibyt , Ltd., IL | BTY |
| Oct 17, 2024 | K242809 | Ascent Cardiorespiratory Diagnostic Software Medical Graphics Corporation | BTY |
| May 28, 2024 | K223629 | SpiroSphere, SpiroSphereECG, CardioSphere Eresearchtechnology GmbH, DE | BTY |
| Feb 21, 2024 | K231561 | Pulmonary Function Tester, Model: A9 Guangzhou Homesun Medical Technology Co., Ltd., CN | BTY |
| Jun 23, 2023 | K222982 | Virtus Metabolic Monitor Virtus Technology Aps, DK | BTY |
| Jul 15, 2022 | K221030 | Model 9100 PFT/DICO Vitalograph Ireland, Ltd., IE | BTY |
| Jan 28, 2021 | K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU Eresearchtechnology GmbH, DE | BTY |
| Feb 6, 2020 | K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors Cosmed Srl, IT | BTY |
| Apr 12, 2019 | K181912 | Ascent Cardiorespiratory Diagnostic Software Medical Graphics Corporation | BTY |
| Feb 15, 2019 | K173937 | SpiroSphere Eresearchtechnology GmbH, DE | BTY |
| Feb 22, 2017 | K161534 | EasyOne Pro Respiratory Analysis System Ndd Medizintechnik AG, CH | BTY |
| Jan 21, 2016 | K150888 | Shape-HF Cardiopulmonary Testing System Shape Medical Systems, Inc. | BTY |
| Nov 19, 2012 | K122699 | SENTRYSUITE PRODUCT LINE Carefusion Germany 234 GmbH, DE | BTY |
| Sep 27, 2012 | K120635 | EASYONE PRO RESPIRATORY TESTING DEVICE Ndd Medizitechnik AG | BTY |
| May 10, 2012 | K113813 | SENTRYSUITE PRODUCT LINE Carefusion Germany 234 GmbH, DE | BTY |
| Aug 12, 2011 | K111053 | SENTRYSUITE PRODUCT LINE Carefusion Germany 234 GmbH, DE | BTY |
| Jan 27, 2010 | K091428 | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM Ndd Medizitechnik AG | BTY |
| Mar 31, 2009 | K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM Shape Medical Systems, Inc. | BTY |
| Dec 2, 2008 | K082539 | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT Cardinal Health Germany 234 GmbH, DE | BTY |
| Aug 20, 2008 | K080510 | VIP PULMONARY FUNCTION SYSTEM Viasys Healthcare GmbH, DE | BTY |
| Jun 26, 2008 | K080734 | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT Viasys Healthcare GmbH, DE | BTY |
| Aug 14, 2007 | K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE Viasys Healthcare GmbH | BTY |
| May 11, 2007 | K062011 | MODIFICATION TO FLOWSCREEN Viasys Healthcare GmbH | BTY |
| Sep 28, 2004 | K040549 | COSMED PONY FX Cosmed Srl | BTY |
| Jul 30, 2003 | K031194 | SPIROSOFT Viasys Healthcare GmbH | BTY |
| Jan 2, 2003 | K020745 | COSMED MICROQUARK Cosmed Srl | BTY |
| Dec 14, 2000 | K993641 | METALYZER, MODEL 2; METALYZER, MODEL 3 Cortex Biophysik GmbH | BTY |
| Mar 29, 2000 | K000648 | SPIRO PRO Erich Jaeger GmbH | BTY |
| Oct 30, 1998 | K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES Sensor Medics Corp. | BTY |
| Jul 28, 1998 | K980094 | MODIFICATION TO THE OXYCONALPHA Erich Jaeger B.V., NL | BTY |
| Feb 14, 1997 | K961252 | DSXL DIFFUSION SPIROMETER Inair , Ltd. | BTY |
| Mar 20, 1995 | K942230 | OXYCON-ALPHA Mijnhardt B.V., NL | BTY |
| Nov 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS Sensor Medics Corp. | BTY |
| Mar 7, 1994 | K933839 | MASTER SCREEN PNUEMO Erich Jaeger, Inc. | BTY |
| Mar 7, 1994 | K932744 | FLOWSCREEN Erich Jaeger, Inc. | BTY |
| Feb 10, 1994 | K933511 | UPGRADED SPIROMETER ST-90 Futuremed Div. of Future Impex Corp. | BTY |
| Dec 17, 1993 | K932278 | PFM PROFESSIONAL 7000 SPIROMETER Advanced Medical Systems, Inc. | BTY |
| Dec 17, 1993 | K921309 | MODEL 508 PATIENT MONITOR Criticare Systems, Inc. | BTY |
| Jul 26, 1993 | K930085 | VITALOGRAPH DATA STORAGE SPIROMETER Vitalograph , Ltd. | BTY |
| Jul 22, 1991 | K911358 | CMD/DLCO DIAGNOSTIC SPIROMETER Spirometrics, Inc. | BTY |
| Oct 27, 1989 | K892705 | EBS2605 INFANT HUGGER Equilibrated Bio Systems, Inc. | BTY |
| Oct 19, 1989 | K894667 | MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP Pneumedics, Inc. | BTY |
| Sep 29, 1988 | K883008 | PULMONARY FORCED FLOW SYSTEM (PUFFS) Medical Associated Services, Inc. | BTY |
| Jun 10, 1988 | K881122 | UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. Medical Associated Services, Inc. | BTY |
| Mar 6, 1987 | K864836 | L.A.P. SPIROMETER Timeter Instrument Corp. | BTY |
| Nov 7, 1986 | K864087 | PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM Medical Associated Services, Inc. | BTY |
| Oct 27, 1986 | K863087 | SPIROLOOP-PULMONARY EXERCISE SYSTEM Pneumedics, Inc. | BTY |
| Jun 23, 1986 | K861487 | ST-90 SPIRO ANALIZER Future Impex Corp. | BTY |
| May 19, 1986 | K861486 | SPIROMETRY MODULE Medical Graphics Corp. | BTY |
| Feb 5, 1986 | K855068 | SPIROMETER, MODEL TS-500 PART #SLZ7534 Teledyne Avionics Div. of Teledyne | BTY |
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