The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Cpr (complete Personal Resusciator) Bag With Expandable Reservoir.
| Device ID | K954866 |
| 510k Number | K954866 |
| Device Name: | MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Contact | Kathy L Hann |
| Correspondent | Kathy L Hann MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-24 |
| Decision Date | 1996-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10641043557181 | K954866 | 000 |
| 30641043557192 | K954866 | 000 |
| 30641043563063 | K954866 | 000 |