RYUSEI
FDA 510(k) clearance K772424 · decided 1978-05-09
Clearance details
- K-number
- K772424
- Device name
- RYUSEI
- Applicant
- Ercona Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-28
- Decision date
- 1978-05-09
- Days to decision
- 132 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
+ Add to Predicate Builder ◉ Watch Ercona Corp.
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 |
|---|---|---|
| POINT LOCATOR STIMULATOR (K792529) | Staodynamics, Inc. | 1980-02-26 |
| PLS MINI (K792501) | Staodynamics, Inc. | 1980-02-26 |
Recalls involving this device
No recalls on record reference this clearance.