1-380 PINWHEEL (WARTENBERG)
FDA 510(k) clearance K851749 · decided 1985-06-13
Clearance details
- K-number
- K851749
- Device name
- 1-380 PINWHEEL (WARTENBERG)
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-06-13
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GWY
- Device class
- 1
- Regulation number
- 882.1750
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Antonio, TX, 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 |
|---|---|---|
| BIS SRS (SEMI-RESUABLE SENSOR) (K050313) | Aspect Medical Systems, Inc. | 2005-02-24 |
| NEURO-AIDE (K942926) | Burke Neutech, Inc. | 1994-08-03 |
| SENSITESTER (K871167) | Dexin Pty. , Ltd. | 1987-04-01 |
| PINWHEEL (K780422) | Projects IN Health | 1978-04-04 |
Recalls involving this device
No recalls on record reference this clearance.