HYDRA TRED DC
FDA 510(k) clearance K801250 · decided 1980-06-17
Clearance details
- K-number
- K801250
- Device name
- HYDRA TRED DC
- Applicant
- Medichanics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-28
- Decision date
- 1980-06-17
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- IOG
- Device class
- 1
- Regulation number
- 890.5370
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 (K920526) | Stryker Medical | 1992-09-21 |
| MT-10, ET-20 (K800251) | Associated Mills, Inc. | 1980-04-02 |
Recalls involving this device
No recalls on record reference this clearance.