ACU220 CRYO UNIT
FDA 510(k) clearance K841294 · decided 1984-08-15
Clearance details
- K-number
- K841294
- Device name
- ACU220 CRYO UNIT
- Applicant
- Keller Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-29
- Decision date
- 1984-08-15
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- HQA
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, 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 |
|---|---|---|
| SERIES 25 SLIMLINE CRYO PROBES (K854422) | Keeler Instruments, Inc. | 1985-12-30 |
| KEELER-COMPACT CRYO SYSTEM (K854411) | Keeler Instruments, Inc. | 1985-12-30 |
| SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (K823835) | Keller Instruments, Inc. | 1983-01-17 |
Recalls involving this device
No recalls on record reference this clearance.