FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RICA (DIAGNOSTIC INSTRUMENTS)
K Number: K810054
·
Decision Jan 28, 1981
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
10
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- RICA (DIAGNOSTIC INSTRUMENTS)
- K Number
- K810054
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1700
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Robert I. Chien & Assoc., Inc.
- Date Received
- January 12, 1981
- Decision Date
- January 28, 1981
- Product Code
- GWZ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWZ | Percussor | FDA class 1 | Neurology |
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H.R. JAKOBI SURG. INSTR. #10 34/36
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Other Clearances by Robert I. Chien & Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822151 | SURGICAL INSTRUMENTS REPRESENT. 4 CLASS | Aug 19, 1982 | Substantially Equivalent |
| K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) | Sep 11, 1981 | Substantially Equivalent |
| K811631 | THERMOMETER (MADE IN CHINA) | Jul 20, 1981 | Substantially Equivalent |
| K801819 | SURGICAL INSTRUMENTS | Aug 20, 1980 | Substantially Equivalent |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | May 20, 1980 | Substantially Equivalent |