The following data is part of a premarket notification filed by Midmark Diagnostics Group with the FDA for Midmark Diagnostics Iqmark Vital Signs Monitor.
| Device ID | K072516 |
| 510k Number | K072516 |
| Device Name: | MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MIDMARK DIAGNOSTICS GROUP 3300 FUJITA STREET Torrance, CA 90505 |
| Contact | Tony Capparelli |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-10-18 |
| Summary: | summary |