FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPIC SMART SCALE CARE CENTER
K Number: K920423
·
Decision Jun 11, 1992
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
5
Applicant Total
37
Review Days
132
Basic Information
- Device Name
- OLYMPIC SMART SCALE CARE CENTER
- K Number
- K920423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OLYMPIC MEDICAL CORP.
- Date Received
- January 31, 1992
- Decision Date
- June 11, 1992
- Product Code
- FEW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FEW | Catheter, Malecot | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEW), ordered by most recent decision date.
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
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BARD MALECOT AND PEZZER DRAINS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANAN MALECOT BASKET DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANAN MALECOT BASKET DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by OLYMPIC MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Jun 20, 2008 | Substantially Equivalent |
| K031149 | OLYMPIC CFM 6000 | May 14, 2003 | Substantially Equivalent |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | Jun 18, 2002 | Substantially Equivalent |
| K001056 | OLYMPIC WARM-UP | Sep 29, 2000 | Substantially Equivalent |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Mar 23, 1999 | Substantially Equivalent |
| K971601 | OLYMPIC BILI-BASSINET | Sep 24, 1997 | Substantially Equivalent |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Sep 5, 1997 | Substantially Equivalent |
| K971117 | WARMETTE | Aug 22, 1997 | Substantially Equivalent |
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | Jan 30, 1996 | Substantially Equivalent |
| K954434 | OLYMPIC INFANT THERMOMETER | Dec 20, 1995 | Substantially Equivalent |