Olympic Smart Scale
FDA 510(k) K871104 · Olympic Medical Corp.
510(k) numberK871104
Submission
- Device name
- Olympic Smart Scale
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- March 19, 1987
- Decision date
- May 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRW – Scale, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2720
- Specialty
- General Hospital
Other 510(k)s with product code FRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | Olympic Medical Corp. | 01/30/1996SE |
| K955177 | Olympic Smart ScaleFRW · Traditional | Olympic Medical Corp. | 12/14/1995SE |
| K954846 | Olympic Smart ScaleFRW · Traditional | Olympic Medical Corp. | 12/14/1995SE |
| K952649 | Warm-ScaleFRW · Traditional | Olympic Medical Corp. | 08/15/1995SE |
| K943587 | Advanced In-Bed Weigh SystemFRW · Traditional | Future Systems, Inc. | 09/22/1994SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | Tanita Corp. of America | 11/16/1993SE |
| K926174 | Model 9100 H.R. Infant ScaleFRW · Traditional | Acme Medical Scale Co. | 10/25/1993SE |
| K926446 | Ez PumpFRW · Traditional | Alphamed, Inc. | 09/27/1993SE |
| K926059 | 3M Model 200RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K926058 | 3M Model 280RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
More from 3M Health Care, Ltd.
| 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 Smart Scale cleared by the FDA?
Olympic Smart Scale (K871104) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 64 days after the submission was received.
What is the product code of K871104?
The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.