The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Model 508 Patient Monitor.
| Device ID | K921309 |
| 510k Number | K921309 |
| Device Name: | MODEL 508 PATIENT MONITOR |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| 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 | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-10 |
| Decision Date | 1993-12-17 |