The following data is part of a premarket notification filed by Anesthesia Assoc., Inc. with the FDA for Universal Control Arm.
Device ID | K833871 |
510k Number | K833871 |
Device Name: | UNIVERSAL CONTROL ARM |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | ANESTHESIA ASSOC., 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 | 1983-11-08 |
Decision Date | 1983-12-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B00500115S0 | K833871 | 000 |
B005001150 | K833871 | 000 |