The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Pm-2100 Vital Sign Monitor.
| Device ID | K022537 |
| 510k Number | K022537 |
| Device Name: | PRESS-MATE PM-2100 VITAL SIGN MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio, TX 78249 |
| Contact | Mark Rison |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-08-01 |
| Decision Date | 2002-09-13 |
| Summary: | summary |