The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Safe Response Mouth-to-mask Resuscitator, Pediatric.
| Device ID | K952169 |
| 510k Number | K952169 |
| Device Name: | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688402646 | K952169 | 000 |