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 |