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 |
|---|---|---|---|
| Jan 30, 1986 | K855069 | SPIROMETER TS-400 SLZ 7547 Teledyne Avionics Div. of Teledyne | BTY |
| Jan 10, 1986 | K854745 | CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM Versacor, Inc. | BTY |
| Nov 29, 1985 | K853433 | ELF Cardio-Respiratory | BTY |
| Feb 14, 1985 | K850045 | SPIROMETRICS 2453 & SMI III Spirometrics, Inc. | BTY |
| Jan 28, 1983 | K823771 | SPIROTECH 300 Spirotech, Inc. | BTY |
| Jan 21, 1983 | K823683 | VITALOGRAPH PFT PRINTER Vitalograph , Ltd. | BTY |
| Jul 26, 1982 | K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 Burditt & Calkins-Siemens-Elema | BTY |
| Dec 3, 1981 | K812850 | PTT-200 PULMONARY RECEIVER/MICROPROCES Pharmaquest Corp. | BTY |
| Dec 3, 1981 | K812849 | PTT-200 TELEPHONIC PULMONARY TRANSMITT Pharmaquest Corp. | BTY |
| Nov 27, 1981 | K812792 | PFT SCREENER (SYSTEM 1100) Medical Graphics Corp. | BTY |
| Mar 24, 1981 | K810712 | ELECTRONIC SPIROMETER MODEL MFR-8100 Nihon Kohden America, Inc. | BTY |
| Dec 22, 1980 | K803053 | APEXLINE OF PULMONARY FUNCT. INSTRUM. Warren E. Collins, Inc. | BTY |
| Apr 4, 1979 | K790579 | MEDISTOR II Cybermedic, Inc. | BTY |
| May 16, 1978 | K780584 | PULMONARY FUNCTION TESTER Warren E. Collins, Inc. | BTY |
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