The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Slimb Single Limb Breathing Circuit.
Device ID | K832453 |
510k Number | K832453 |
Device Name: | SLIMB SINGLE LIMB BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | RESPIRATORY CARE, 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 | 1983-07-26 |
Decision Date | 1983-10-27 |