The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Hyperinflation Bag System, Model 83-900-0149.
| Device ID | K001714 |
| 510k Number | K001714 |
| Device Name: | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Contact | Ron Rupenski |
| Correspondent | Ron Rupenski MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-11-03 |