A-SCAN ROLL-AROUND STAND
FDA 510(k) clearance K900161 · decided 1990-02-16
Clearance details
- K-number
- K900161
- Device name
- A-SCAN ROLL-AROUND STAND
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-12
- Decision date
- 1990-02-16
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HMG
- Device class
- 1
- Regulation number
- 886.1860
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, 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 |
|---|---|---|
| MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE (K883575) | Site Microsurgical Systems, Inc. | 1988-09-12 |
| GORSK INSTRUMENT REST (K873554) | Gorsk, Inc. | 1987-10-23 |
| OPHTHALMIC TABLE (K841759) | Woodlyn, Inc. | 1984-06-01 |
Recalls involving this device
No recalls on record reference this clearance.