HEMOREST(TM)
FDA 510(k) clearance K864470 · decided 1987-06-23
Clearance details
- K-number
- K864470
- Device name
- HEMOREST(TM)
- Applicant
- Health Aid Products
- Decision
- Substantially Equivalent
- Date received
- 1986-11-12
- Decision date
- 1987-06-23
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- LRL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Miami Lakes, FL, 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 |
|---|---|---|
| HEMAWAY SEAT (K072690) | Hemaway, LLC | 2007-12-07 |
| PERI-COMFORT(TM) SEATING CUSHION (K932396) | Chi'Am Intl. | 1993-09-30 |
Recalls involving this device
No recalls on record reference this clearance.