VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
FDA 510(k) clearance K851102 · decided 1985-05-16
Clearance details
- K-number
- K851102
- Device name
- VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
- Applicant
- Sonicaid, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-19
- Decision date
- 1985-05-16
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- DQB
- Device class
- 2
- Regulation number
- 870.2750
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fredericksburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEVETHERM (K822873) | Eko Scann AB | 1983-03-24 |
| IMPEDANCE RHEOGRAPH (K772093) | Dynatech Research & Development Co. | 1977-11-18 |
Recalls involving this device
No recalls on record reference this clearance.