APNEACHECK
Ventilatory Effort Recorder
IM SYSTEMS
The following data is part of a premarket notification filed by Im Systems with the FDA for Apneacheck.
Pre-market Notification Details
| Device ID | K022294 |
| 510k Number | K022294 |
| Device Name: | APNEACHECK |
| Classification | Ventilatory Effort Recorder |
| Applicant | IM SYSTEMS 1055 TAYLOR AVE. SUITE 300 Baltimore, MD 21286 |
| Contact | David T Krausman |
| Correspondent | David T Krausman IM SYSTEMS 1055 TAYLOR AVE. SUITE 300 Baltimore, MD 21286 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-16 |
| Decision Date | 2003-04-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959020566 | K022294 | 000 |
| 00606959020405 | K022294 | 000 |
| 00606959029156 | K022294 | 000 |
| 00606959029149 | K022294 | 000 |
| 00606959029132 | K022294 | 000 |
| 00606959029125 | K022294 | 000 |
Trademark Results [APNEACHECK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APNEACHECK 75744264 not registered Dead/Abandoned |
Individual Monitoring Systems, Inc. 1999-07-06 |
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