SENSITESTER
FDA 510(k) clearance K871167 · decided 1987-04-01
Clearance details
- K-number
- K871167
- Device name
- SENSITESTER
- Applicant
- Dexin Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-24
- Decision date
- 1987-04-01
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- GWY
- Device class
- 1
- Regulation number
- 882.1750
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Western Australia, AU
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dexin Pty.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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.