The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Universal Physiological Measurement Module.
| Device ID | K091985 |
| 510k Number | K091985 |
| Device Name: | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Dick Listro |
| Correspondent | Dick Listro IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816396022225 | K091985 | 000 |
| 00816396022164 | K091985 | 000 |
| 00816396022157 | K091985 | 000 |
| 00816396021990 | K091985 | 000 |
| 00816396020825 | K091985 | 000 |
| 00816396020818 | K091985 | 000 |
| 00816396023178 | K091985 | 000 |
| 00816396021563 | K091985 | 000 |