Olympic Warmette
FDA 510(k) K911955 · Olympic Medical Corp.
510(k) numberK911955
Submission
- Device name
- Olympic Warmette
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- May 1, 1991
- Decision date
- July 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
No product code recorded.
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| K981032 | Piv SystemLDQ · Traditional | Medical Solutions, Inc. | 09/02/1998SE |
| K973747 | Controlled Temperature Cabinet SystemLDQ · Traditional | Smith | 05/07/1998SE |
| K955661 | Acu-HaltLDQ · Traditional | Glederer & Co., Inc. | 12/30/1996SE |
| K955776 | Acu-LabLDQ · Traditional | Glederer & Co., Inc. | 06/05/1996SE |
| K945374 | Acu-HaltLDQ · Traditional | Eva-Health USA, Inc. | 08/09/1995SE |
| K944961 | Personal Alarm System (Pas)LDQ · Traditional | Cytoprobe Corp. | 08/07/1995SE |
| K942810 | Palco Labs Cold PouchLDQ · Traditional | Palco Laboratories, Inc. | 06/28/1995SE |
| K930884 | Medical Procedure Tray, ModificationLDQ · Traditional | Enpak Medical Corp. | 03/21/1995SE |
More from Enpak Medical Corp.
| 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 |
| 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 Warmette cleared by the FDA?
Olympic Warmette (K911955) received a 510(k) decision of Substantially Equivalent on July 19, 1991, 79 days after the submission was received.