FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPIC INFA-LENGTH
K Number: K932112
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
398
Registration Numbers
398
Same Product Code
22
Applicant Total
37
Review Days
80
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 INFA-LENGTH
- K Number
- K932112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympic Medical Corp.
- Date Received
- May 3, 1993
- Decision Date
- July 22, 1993
- Product Code
- FTY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTY), ordered by most recent decision date.
Noxilizer Surgical Ruler
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OLYMPIC AUTO-LENGTH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER PRESSURE MONITOR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TUMORIMETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |