BIS SRS (SEMI-RESUABLE SENSOR)
FDA 510(k) clearance K050313 · decided 2005-02-24
Clearance details
- K-number
- K050313
- Device name
- BIS SRS (SEMI-RESUABLE SENSOR)
- Applicant
- Aspect Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-09
- Decision date
- 2005-02-24
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GWY
- Device class
- 1
- Regulation number
- 882.1750
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Newton, MA, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| NEURO-AIDE (K942926) | Burke Neutech, Inc. | 1994-08-03 |
| SENSITESTER (K871167) | Dexin Pty. , Ltd. | 1987-04-01 |
| 1-380 PINWHEEL (WARTENBERG) (K851749) | Artiberia | 1985-06-13 |
| PINWHEEL (K780422) | Projects IN Health | 1978-04-04 |
Recalls involving this device
No recalls on record reference this clearance.