Olympic Trans-Lite
FDA 510(k) K920782 · Olympic Medical Corp.
510(k) numberK920782
Submission
- Device name
- Olympic Trans-Lite
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- February 20, 1992
- Decision date
- March 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYT – Light, Examination, Medical, Battery Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6350
- Specialty
- General Hospital
Other 510(k)s with product code KYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841589 | C-LiteKYT · Traditional | Suncoast Medical Manufacturers, Inc. | 05/22/1984SE |
| K841588 | Sun-Lite White SpotKYT · Traditional | Suncoast Medical Manufacturers, Inc. | 05/22/1984SE |
| K791001 | Penlight/Swab HolderKYT · Traditional | Concept, Inc. | 06/22/1979SE |
| K781228 | PenlightsKYT · Traditional | Abco Dealers, Inc. | 09/07/1978SE |
| K760972 | Tycos Diagnostic PenlightKYT · Traditional | Taylor Instrument Analytics Co. | 01/26/1977SE |
More from Taylor Instrument Analytics Co.
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| K031149 | Olympic CFM 6000OMA · Special | 05/14/2003SE |
| K020335 | Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330OMC · Traditional | 06/18/2002SE |
| K001056 | Olympic Warm-UpILY · Traditional | 09/29/2000SE |
| K983229 | Olympic Medical Lectromed Cerebral Function Monitor SystemOMA · Traditional | 03/23/1999SE |
| K971601 | Olympic Bili-BassinetLBI · Traditional | 09/24/1997SE |
| K972193 | Olympix Mini-Pasteurmatic (58210)LDS · Traditional | 09/05/1997SE |
| K971117 | WarmetteLHC · Traditional | 08/22/1997SE |
| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | 01/30/1996SE |
| K954434 | Olympic Infant ThermometerFLL · Traditional | 12/20/1995SE |
Questions and answers
When was Olympic Trans-Lite cleared by the FDA?
Olympic Trans-Lite (K920782) received a 510(k) decision of Substantially Equivalent on March 27, 1992, 36 days after the submission was received.
What is the product code of K920782?
The FDA product code is KYT – Light, Examination, Medical, Battery Powered, a Class I (low risk) device regulated under 21 CFR 880.6350.