The following data is part of a premarket notification filed by Khi, Inc. with the FDA for Khi Cpram Breathing Circuit.
| Device ID | K811858 |
| 510k Number | K811858 |
| Device Name: | KHI CPRAM BREATHING CIRCUIT |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | KHI, 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 | 1981-07-01 |
| Decision Date | 1981-07-16 |