Model 9100 H.R. Infant Scale
FDA 510(k) K926174 · Acme Medical Scale Co.
510(k) numberK926174
Submission
- Device name
- Model 9100 H.R. Infant Scale
- Applicant
- Acme Medical Scale Co.
San Leandro, CA, US - Received
- December 8, 1992
- Decision date
- October 25, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRW – Scale, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2720
- Specialty
- General Hospital
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| K926058 | 3M Model 280RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K930626 | Sanitas Patient ScaleFRW · Traditional | Dutton-Lainson Co. | 08/06/1993SE |
More from Dutton-Lainson Co.
| 510(k) | Device | Decision |
|---|---|---|
| K922119 | Model 5002 Lift Weigh-ScaleFRW · Traditional | 02/03/1993SE |
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| K852278 | Acme(Brand) Low-Profile Wheelchair Scale, 17400FRW · Traditional | 06/07/1985SE |
| K851014 | Acme Low-Profile Chair Scal 7300FRW · Traditional | 03/27/1985SE |
| K841534 | Acme Digital Infant SCALE-30FRW · Traditional | 05/31/1984SE |
| K830171 | Digital Bedside Scale #5000FRW · Traditional | 02/18/1983SE |
| K790130 | Scale, Digital ChairFRI · Traditional | 02/01/1979SE |
| K781832 | Scale, Acme Digital BedsideFRW · Traditional | 12/07/1978SE |
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Questions and answers
When was Model 9100 H.R. Infant Scale cleared by the FDA?
Model 9100 H.R. Infant Scale (K926174) received a 510(k) decision of Substantially Equivalent on October 25, 1993, 321 days after the submission was received.
What is the product code of K926174?
The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.