OxyMinder
Analyzer, Gas, Oxygen, Gaseous-phase
Bio-Med Devices, Inc.
The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Oxyminder.
Pre-market Notification Details
| Device ID | K213948 |
| 510k Number | K213948 |
| Device Name: | OxyMinder |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | Bio-Med Devices, Inc. 61 Soundview Rd Guilford, CT 06437 |
| Contact | Ken K Close |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-03-17 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813841022298 | K213948 | 000 |
| 00813841022281 | K213948 | 000 |
Trademark Results [OxyMinder]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYMINDER 90203713 not registered Live/Pending |
Bio-Med Devices, Inc. 2020-09-23 |
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