OB HELP ARM
FDA 510(k) clearance K830842 · decided 1983-04-05
Clearance details
- K-number
- K830842
- Device name
- OB HELP ARM
- Applicant
- Lic-Orthion
- Decision
- Substantially Equivalent
- Date received
- 1983-03-17
- Decision date
- 1983-04-05
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- ILE
- Device class
- 1
- Regulation number
- 890.3475
- 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 |
|---|---|---|
| OVERHEAD ARM SLINGS (K823811) | Danek Medical, Inc. | 1983-01-14 |
| OB HELP ARM (K823152) | Orthion Corp. | 1982-11-05 |
Recalls involving this device
No recalls on record reference this clearance.