POINT LOCATOR STIMULATOR
FDA 510(k) clearance K792529 · decided 1980-02-26
Clearance details
- K-number
- K792529
- Device name
- POINT LOCATOR STIMULATOR
- Applicant
- Staodynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-07
- Decision date
- 1980-02-26
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- BWJ
- Device class
- 2
- Regulation number
- 880.5580
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PLS MINI (K792501) | Staodynamics, Inc. | 1980-02-26 |
| RYUSEI (K772424) | Ercona Corp. | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.