The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for 1st Response Reusable Manual Resuscitator (adult).
| Device ID | K900577 |
| 510k Number | K900577 |
| Device Name: | 1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James W Pope |
| Correspondent | James W Pope 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 | 1990-02-07 |
| Decision Date | 1990-07-16 |