FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
K Number: K854969
·
Decision Feb 27, 1986
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
12
Review Days
78
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Basic Information
- Device Name
- CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN)
- K Number
- K854969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cilco, Inc.
- Date Received
- December 11, 1985
- Decision Date
- February 27, 1986
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Cilco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | May 2, 1986 | Substantially Equivalent |
| K844249 | K-SOL | Apr 30, 1985 | Substantially Equivalent |
| K843319 | CILCO I/A SURGICAL PACK | Feb 14, 1985 | Substantially Equivalent |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Nov 21, 1984 | Substantially Equivalent |
| K843447 | CILCO DIAMOND KNIFE | Oct 5, 1984 | Substantially Equivalent |
| K841099 | OCTOPUS 500/500E | Jun 19, 1984 | Substantially Equivalent |
| K840475 | CYSTOTOME, 140-S | Apr 5, 1984 | Substantially Equivalent |
| K832405 | OPTHALMIC ENDOSCOPE | Nov 21, 1983 | Substantially Equivalent |
| K827371 | CILCO ASCAN | Jul 9, 1982 | Substantially Equivalent |
| K820933 | CILCO I/A HANDPIECE | Jun 14, 1982 | Substantially Equivalent |