SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
FDA 510(k) clearance K900472 · decided 1990-09-04
Clearance details
- K-number
- K900472
- Device name
- SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-31
- Decision date
- 1990-09-04
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- HBN
- Device class
- 1
- Regulation number
- 882.4125
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Grand Rapids, MI, 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 |
|---|---|---|
| MCINTYRE MICROSCOPE STAND (K822426) | Surgi-Quip Inc.U | 1982-09-02 |
| SURGI-QUIP MICROSCOPE STAND (K822428) | Surgi-Quip Inc.U | 1982-09-02 |
| BINOCULAR OPERATING MICROSCOPES & (K822012) | Kelleher Corp. | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.