The following data is part of a premarket notification filed by Midmark Corporation with the FDA for Iqvitals Zone.
| Device ID | K161909 |
| 510k Number | K161909 |
| Device Name: | IQvitals Zone |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Midmark Corporation 690 Knox Street, Suite 100 Torrance, CA 90502 |
| Contact | Asad Abu-tarif |
| Correspondent | Maria Moreno Midmark Corporation 690 Knox Street, Suite 100 Torrance, CA 90502 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709105913 | K161909 | 000 |
| 00841709105807 | K161909 | 000 |
| 00841709105814 | K161909 | 000 |
| 00841709105821 | K161909 | 000 |
| 00841709105838 | K161909 | 000 |
| 00841709105869 | K161909 | 000 |
| 00841709105876 | K161909 | 000 |
| 00841709105883 | K161909 | 000 |
| 00841709105890 | K161909 | 000 |
| 00841709105906 | K161909 | 000 |
| 00841709105784 | K161909 | 000 |