The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Sims Intertech Hyperinflation Bag System.
| Device ID | K952214 |
| 510k Number | K952214 |
| Device Name: | SIMS INTERTECH HYPERINFLATION BAG SYSTEM |
| Classification | Resuscitator, Manual, Non Self-inflating |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Avia Toney |
| Correspondent | Avia Toney INTERTECH RESOURCES, INC. 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 | 1995-05-11 |
| Decision Date | 1995-06-08 |