Sanitas Patient Scale

FDA 510(k) K930626 · Dutton-Lainson Co.

Substantially Equivalent

510(k) numberK930626

Submission

Device name
Sanitas Patient Scale
Applicant
Dutton-Lainson Co.
Hastings, NE, US
Received
February 8, 1993
Decision date
August 6, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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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More from 3M Health Care, Ltd.

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Questions and answers

When was Sanitas Patient Scale cleared by the FDA?

Sanitas Patient Scale (K930626) received a 510(k) decision of Substantially Equivalent on August 6, 1993, 179 days after the submission was received.

What is the product code of K930626?

The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.