Panels › Anesthesiology › Product code MNR · Class 2
Ventilatory Effort Recorder
Regulation 868.2375
6510(k)s in 12 months (165 all time)
1recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in MNR
| Company | 510(k)s | Recalls |
|---|---|---|
| Itamar Medical | 15 | 0 |
| Respironics, Inc. | 6 | 2 |
| Advanced Brain Monitoring | 6 | 0 |
| Snap Laboratories, LLC | 6 | 0 |
| Compumedics Limited | 5 | 0 |
| Embla Systems | 5 | 0 |
| Resmed Germany, Inc. | 5 | 0 |
| Huxley Medical | 4 | 0 |
| Medcare Flaga | 4 | 0 |
| Somnomedics GmbH | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 1998 | K981034 | SILENT NIGHT II Sleep Solutions, Inc. | MNR |
| Jul 13, 1998 | K982293 | PRESSURE TRANSDUCER AIRFLOW SENSOR Pro-Tech Services, Inc. | MNR |
| May 14, 1998 | K973920 | STARDUST Respironics, Inc. | MNR |
| Nov 12, 1997 | K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 Neurotronics, Inc. | MNR |
| Oct 14, 1997 | K971501 | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER Bio-Logic Systems Corp. | MNR |
| Oct 1, 1997 | K971184 | OXI-SNAP Snap Laboratories, LLC | MNR |
| Mar 11, 1997 | K955841 | SLEEP SYSTEM FOR CLINICS & RESEARCH Compumedics Ptd , Ltd. | MNR |
| Feb 4, 1997 | K964494 | SLEEPWIZARD Nellcor Puritan Bennett, Inc. | MNR |
| Jan 23, 1997 | K963597 | SILENT NIGHT I Local Silence, Inc. | MNR |
| Aug 22, 1996 | K962103 | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER Bio-Logic Systems Corp. | MNR |
| Oct 26, 1995 | K944524 | SNAP TESTING DEVICE Snap Laboratories, LLC | MNR |
| Sep 19, 1995 | K950273 | SLEEP TEST(TM) Cns, Inc. | MNR |
| May 4, 1995 | K940013 | BODY POSITION INDICATOR, MODEL BPI1 Pro-Tech, Inc. | MNR |
| Apr 21, 1995 | K944611 | MODEL# 7500 SURVEYOR Devilbiss Health Care, Inc. | MNR |
| Jan 11, 1995 | K940015 | SNORING MICROPHONE, SM1 Pro-Tech, Inc. | MNR |
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