The following data is part of a premarket notification filed by Emergency Medical Techology with the FDA for Emt-cpap.
| Device ID | K021520 |
| 510k Number | K021520 |
| Device Name: | EMT-CPAP |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | EMERGENCY MEDICAL TECHOLOGY 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland EMERGENCY MEDICAL TECHOLOGY 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850071887242 | K021520 | 000 |
| 00850071887174 | K021520 | 000 |
| 00850071887136 | K021520 | 000 |
| 00850071887013 | K021520 | 000 |