The following data is part of a premarket notification filed by Obs Medical with the FDA for Visensia, Visensia With Alert.
| Device ID | K110953 |
| 510k Number | K110953 |
| Device Name: | VISENSIA, VISENSIA WITH ALERT |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | OBS MEDICAL ROSEMARY HOUSE 31 CHURCH GREEN STANFORD In The Vale Oxford, GB Sn7 8hu |
| Contact | Chris Weatherall |
| Correspondent | Chris Weatherall OBS MEDICAL ROSEMARY HOUSE 31 CHURCH GREEN STANFORD In The Vale Oxford, GB Sn7 8hu |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-05 |
| Decision Date | 2011-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060457930010 | K110953 | 000 |