The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Breathing Circuit Products, Anesthesia.
Device ID | K781908 |
510k Number | K781908 |
Device Name: | BREATHING CIRCUIT PRODUCTS, ANESTHESIA |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | HOSPITAK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-14 |
Decision Date | 1978-11-27 |