The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Poet Iq With Five Agent Capability.
| Device ID | K942737 |
| 510k Number | K942737 |
| Device Name: | POET IQ WITH FIVE AGENT CAPABILITY |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Contact | Alex Kaplan |
| Correspondent | Alex Kaplan CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee, WI 53226 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1995-02-09 |