FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
OLYMPUS MOBILE CHAIR/COUCH
K Number: K962528
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
1
Applicant Total
6
Review Days
168
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Basic Information
- Device Name
- OLYMPUS MOBILE CHAIR/COUCH
- K Number
- K962528
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
- Date Received
- June 27, 1996
- Decision Date
- December 12, 1996
- Product Code
- FZK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FZK | Chair, Surgical, Non-Electrical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZK), ordered by most recent decision date.
View allOther Clearances by Keymed (Medical & Industrial Equipment), Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | Sep 13, 2010 | Substantially Equivalent |
| K011725 | OLYMPUS SUCTION PUMP, MODEL KV-5 | Aug 31, 2001 | Substantially Equivalent |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | May 12, 2000 | Substantially Equivalent |
| K930852 | OLYMPUS SUCTION PUMP MODEL KV-4 | Mar 31, 1994 | Substantially Equivalent |
| K881478 | MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS | Sep 14, 1988 | Substantially Equivalent |