2000 Modular Thirty-Nine

FDA 510(k) K962763 · Equi-Tron Mfg., Inc.

Substantially Equivalent

510(k) numberK962763

Submission

Device name
2000 Modular Thirty-Nine
Applicant
Equi-Tron Mfg., Inc.
Milton, Ontario, CA
Received
July 16, 1996
Decision date
October 7, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FNL – Bed, Ac-Powered Adjustable Hospital
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5100
Specialty
General Hospital

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Questions and answers

When was 2000 Modular Thirty-Nine cleared by the FDA?

2000 Modular Thirty-Nine (K962763) received a 510(k) decision of Substantially Equivalent on October 7, 1996, 83 days after the submission was received.

What is the product code of K962763?

The FDA product code is FNL – Bed, Ac-Powered Adjustable Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5100.