The following data is part of a premarket notification filed by Sims with the FDA for Sims 1st Response Manual Resuscitator, Adult.
| Device ID | K972283 |
| 510k Number | K972283 |
| Device Name: | SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-19 |
| Decision Date | 1997-09-17 |