Olympix Mini-Pasteurmatic (58210)
FDA 510(k) K972193 · Olympic Medical Corp.
510(k) numberK972193
Submission
- Device name
- Olympix Mini-Pasteurmatic (58210)
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- June 10, 1997
- Decision date
- September 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDS – Device, Pasteurization, Hot Water
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6991
- Specialty
- General Hospital
Other 510(k)s with product code LDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT…LDS · Traditional | Cenorin, LLC | 09/09/2019SE |
| K031799 | Miele Dental Thermal Disinfector, Model G7881LDS · Special | Miele, Inc. | 11/12/2003SE |
| K983068 | Reliance Family of Washer-DisinfectorsLDS · Traditional | STERIS Corporation | 05/31/2000SE |
| K950518 | Miele G 7781 Dental Thermal DisinfectorLDS · Traditional | Miele Professional | 01/26/1996SE |
| K950566 | Decomat 4656LDS · Traditional | Getinge Disinfection, Inc. | 10/19/1995SE |
| K953645 | Olympic Pasteurmatic SystemLDS · Traditional | Olympic Medical Corp. | 09/22/1995SE |
| K884151 | Model G7731D Washer/Disinfector for Dental Instru.LDS · Traditional | Miele Appliances, Inc. | 05/16/1989SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | Castle Co. | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | Castle Co. | 01/14/1985SE |
| K810311 | Steri-VersLDS · Traditional | The Hilrad Co. | 04/17/1981SE |
More from The Hilrad Co.
| 510(k) | Device | Decision |
|---|---|---|
| K081094 | Olympic Pasteurmatic, Models 3000 and 3500MEC · Special | 06/20/2008SE |
| 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 |
| 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 |
| K955177 | Olympic Smart ScaleFRW · Traditional | 12/14/1995SE |
Questions and answers
When was Olympix Mini-Pasteurmatic (58210) cleared by the FDA?
Olympix Mini-Pasteurmatic (58210) (K972193) received a 510(k) decision of Substantially Equivalent on September 5, 1997, 87 days after the submission was received.
What is the product code of K972193?
The FDA product code is LDS – Device, Pasteurization, Hot Water, a Class II (moderate risk) device regulated under 21 CFR 880.6991.