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 |
| 30351688423249 | K970785 | 000 |
| 30351688420620 | K970785 | 000 |
| 30351688420613 | K970785 | 000 |
| 30351688420583 | K970785 | 000 |
| 30351688420576 | K970785 | 000 |
| 30351688420545 | K970785 | 000 |
| 30351688420521 | K970785 | 000 |
| 30351688420514 | K970785 | 000 |
| 30351688420507 | K970785 | 000 |
| 30351688416944 | K970785 | 000 |
| 30351688411741 | K970785 | 000 |
| 30351688407577 | K970785 | 000 |
| 30351688406396 | K970785 | 000 |
| 30351688423263 | K970785 | 000 |
| 30351688423294 | K970785 | 000 |
| 30351688423300 | K970785 | 000 |
| 30351688423287 | K970785 | 000 |
| 30351688423270 | K970785 | 000 |
| 30351688423256 | K970785 | 000 |
| 30351688435709 | K970785 | 000 |
| 30351688435655 | K970785 | 000 |
| 30351688435334 | K970785 | 000 |
| 30351688430926 | K970785 | 000 |
| 30351688425458 | K970785 | 000 |
| 30351688425403 | K970785 | 000 |
| 30351688424284 | K970785 | 000 |
| 30351688424154 | K970785 | 000 |
| 30351688424147 | K970785 | 000 |
| 30351688423317 | K970785 | 000 |
| 30351688403937 | K970785 | 000 |