FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OLYMPIC WARMETTE
K Number: K911955
·
Decision Jul 19, 1991
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
37
Review Days
79
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Basic Information
- Device Name
- OLYMPIC WARMETTE
- K Number
- K911955
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympic Medical Corp.
- Date Received
- May 1, 1991
- Decision Date
- July 19, 1991
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDQ), ordered by most recent decision date.
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 |