The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Reusable Cpr Bag.
| Device ID | K970756 |
| 510k Number | K970756 |
| Device Name: | MERCURY MEDICAL REUSABLE CPR BAG |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Contact | Arthur J Ward |
| Correspondent | Arthur J Ward MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043507357 | K970756 | 000 |
| 30641043507012 | K970756 | 000 |
| 30641043507029 | K970756 | 000 |
| 30641043507043 | K970756 | 000 |
| 30641043507050 | K970756 | 000 |
| 30641043507074 | K970756 | 000 |
| 30641043507166 | K970756 | 000 |
| 30641043507173 | K970756 | 000 |
| 30641043507180 | K970756 | 000 |
| 30641043507197 | K970756 | 000 |
| 30641043507241 | K970756 | 000 |
| 30641043507319 | K970756 | 000 |
| 30641043507326 | K970756 | 000 |
| 30641043507333 | K970756 | 000 |
| 30641043507340 | K970756 | 000 |
| 30641043507005 | K970756 | 000 |