The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for 503 Maxi Compressor.
Device ID | K940630 |
510k Number | K940630 |
Device Name: | 503 MAXI COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
Contact | Mark D Hebenstreit |
Correspondent | Mark D Hebenstreit MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-14 |
Decision Date | 1995-02-21 |