FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPIC TRANS-LITE
K Number: K920782
·
Decision Mar 27, 1992
Classifications
1
FEI Numbers
156
Registration Numbers
156
Same Product Code
5
Applicant Total
37
Review Days
36
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Basic Information
- Device Name
- OLYMPIC TRANS-LITE
- K Number
- K920782
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6350
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympic Medical Corp.
- Date Received
- February 20, 1992
- Decision Date
- March 27, 1992
- Product Code
- KYT
- 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 |
|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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PENLIGHTS
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TYCOS DIAGNOSTIC PENLIGHT
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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 |