The following data is part of a premarket notification filed by Sims with the FDA for Sims Hyperinflation Bag System.
| Device ID | K970785 |
| 510k Number | K970785 |
| Device Name: | SIMS HYPERINFLATION BAG SYSTEM |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | SIMS 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Avia Toney |
| Correspondent | Avia Toney SIMS 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | NHK |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688424277 | K970785 | 000 |
| 30351688423287 | K970785 | 000 |
| 30351688423270 | K970785 | 000 |
| 30351688423256 | K970785 | 000 |