HYPEX
FDA 510(k) clearance K895274 · decided 1990-02-23
Clearance details
- K-number
- K895274
- Device name
- HYPEX
- Applicant
- Global Business, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-23
- Decision date
- 1990-02-23
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- BYW
- Device class
- 1
- Regulation number
- 868.5675
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Midlothian, VA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Global Business
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 |
|---|---|---|
| SHERWOOD VENTILATORY MUSCLE TRAINER (K802165) | Sherwood Medical Co. | 1980-09-26 |
Recalls involving this device
No recalls on record reference this clearance.