The following data is part of a premarket notification filed by Innokas Yhtyma with the FDA for Vc150 Vital Signs Monitor.
| Device ID | K133810 |
| 510k Number | K133810 |
| Device Name: | VC150 VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INNOKAS YHTYMA TARJUSOJANTIE 12 Kempele, Oulu, FI 90440 |
| Contact | Tiina Kotipalo |
| Correspondent | Tiina Kotipalo INNOKAS YHTYMA TARJUSOJANTIE 12 Kempele, Oulu, FI 90440 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682117722 | K133810 | 000 |