510(k) K841294
K841294 is an FDA 510(k) premarket notification submitted by Keller Instruments, Inc. for the device "ACU220 CRYO UNIT". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code HQA (Unit, Cryotherapy, Ophthalmic), a Class II device regulated under 21 CFR 886.4170. Keller Instruments, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1984
- Date Received
- March 29, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Cryotherapy, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4170
- Review Panel
- OP
- Submission Type