FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KEELER CTU CRYO SYSTEM
K Number: K873388
·
Decision Nov 13, 1987
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
60
Review Days
81
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Basic Information
- Device Name
- KEELER CTU CRYO SYSTEM
- K Number
- K873388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keeler Instruments, Inc.
- Date Received
- August 24, 1987
- Decision Date
- November 13, 1987
- Product Code
- HPS
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HPS | Unit, Cryophthalmic | FDA class 2 | Ophthalmic |
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| K992954 | KEELER CRYO MASTER & PROBES | Dec 21, 1999 | Substantially Equivalent |
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| K973064 | KEELER TEARSCOPE-PLUS | Apr 7, 1998 | Substantially Equivalent |