FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
K Number: K081094
·
Decision Jun 20, 2008
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
1
Applicant Total
37
Review Days
64
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
- K Number
- K081094
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6992
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympic Medical Corp.
- Date Received
- April 17, 2008
- Decision Date
- June 20, 2008
- Product Code
- MEC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MEC | Disinfector, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEC), ordered by most recent decision date.
View allOther Clearances by Olympic Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K954846 | OLYMPIC SMART SCALE | Dec 14, 1995 | Substantially Equivalent |