The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Circuit Breathing.
Device ID | K840740 |
510k Number | K840740 |
Device Name: | CIRCUIT BREATHING |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | MARQUEST MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-17 |
Decision Date | 1984-04-17 |