MODEL 1700, HYDRO PREP
FDA 510(k) clearance K970694 · decided 1997-05-14
Clearance details
- K-number
- K970694
- Device name
- MODEL 1700, HYDRO PREP
- Applicant
- Physiometrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-25
- Decision date
- 1997-05-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GYB
- Device class
- 2
- Regulation number
- 882.1275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- North Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use recall (Z-0704-2020) | Bio-Signal Group Corp. | 2019-12-18 |
| HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Produc recall (Z-0705-2020) | Bio-Signal Group Corp. | 2019-12-18 |