The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Pulse Cuff Recorder Model Pcr100.
| Device ID | K863702 |
| 510k Number | K863702 |
| Device Name: | PULSE CUFF RECORDER MODEL PCR100 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Ed Bistrick |
| Correspondent | Ed Bistrick IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1987-06-12 |