Euro Tech Sterling Roller Table

FDA 510(k) K943973 · Progressive Electrical Therapeutics

Substantially Equivalent

510(k) numberK943973

Submission

Device name
Euro Tech Sterling Roller Table
Applicant
Progressive Electrical Therapeutics
Nevada, MO, US
Received
August 15, 1994
Decision date
September 29, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JFB – Table, Physical Therapy, Multi Function
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5880
Specialty
Physical Medicine

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More from Ceragem International, Inc.

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K933197The Signature Series, M IVGZJ · Traditional 06/02/1995SE
K943972Euro Tech Diamond Chiropractic TableINQ · Traditional 10/11/1994SE
K943975Euro Tech Platinum Chiropractic TableINW · Traditional 09/29/1994SE
K943974Euro Tech Marquise Chiropractic TableINW · Traditional 09/29/1994SE
K933194The Signature Series, Imc IVIPF · Traditional 07/13/1994SE
K933196The Signature Series, Ic IIIPF · Traditional 07/12/1994SE
K934919The Signature Series, Magnum 100IPF · Traditional 04/06/1994SE
K933195The Signature Series, Ic IVIPF · Traditional 02/23/1994SN
K914394Back MasterBXB · Traditional 11/13/1991SE

Questions and answers

When was Euro Tech Sterling Roller Table cleared by the FDA?

Euro Tech Sterling Roller Table (K943973) received a 510(k) decision of Substantially Equivalent on September 29, 1994, 45 days after the submission was received.

What is the product code of K943973?

The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.