Battery Pack

FDA 510(k) K924798 · Portable Power Systems, Inc.

Substantially Equivalent

510(k) numberK924798

Submission

Device name
Battery Pack
Applicant
Portable Power Systems, Inc.
Parker, CO, US
Received
September 24, 1992
Decision date
October 16, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

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More from H&abyz Co., Ltd.

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K945043Battery Pack #PMX120-18AIZL · Traditional 01/20/1995SE
K934508Battery Pack# S1024NCLDD · Traditional 02/17/1994SE
K934439Rechargeable Battery Pack for Critikon 8100 Vital Signs MonitorDPS · Traditional 02/17/1994SE
K934015Recharge Replace Battery PK Spacelabs 4045 Mon/DefibLDD · Traditional 02/17/1994SE
K933065Battery Pack# S1009LADPS · Traditional 02/17/1994SE
K932823Battery Pack# S1018LA for Ivac 4000, 4200 Vital CheckDXN · Traditional 02/17/1994SE
K931484Replacement Batter for Abbott Labs Lifecare 4100 SBZD · Traditional 02/17/1994SE
K931483Replacement Batery for GE AMX-4 Port. X-Ray Mach.IZL · Traditional 02/17/1994SE

Questions and answers

When was Battery Pack cleared by the FDA?

Battery Pack (K924798) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 22 days after the submission was received.

What is the product code of K924798?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.