VSM MODELS A & B
FDA 510(k) clearance K851916 · decided 1985-08-19
Clearance details
- K-number
- K851916
- Device name
- VSM MODELS A & B
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-02
- Decision date
- 1985-08-19
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- DRT
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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| Sleepiz One+ (K223163) | Sleepiz AG | 2023-08-18 |
| Neteera 130H/131H Vital Sign Monitoring Sensor (K212143) | Neteera Technologies , Ltd. | 2022-09-28 |
| Cardiac Trigger Monitor (K202138) | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| Vital Sign Monitoring Sensor (Model :XK300) (K202464) | Xandar Kardian, Inc. | 2021-04-26 |
| Philips wearable biosensor-G5 Solution (K181165) | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
Recalls involving this device
No recalls on record reference this clearance.