Battery Pack 1017LA
FDA 510(k) K931716 · Portable Power Systems, Inc.
510(k) numberK931716
Submission
- Device name
- Battery Pack 1017LA
- Applicant
- Portable Power Systems, Inc.
Castle Rock, CO, US - Received
- April 6, 1993
- Decision date
- February 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
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| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K970234 | Sealed Lead Acid Battery PackIZL · Traditional | 05/02/1997SE |
| K946080 | Physio Control Lifepak 200 Auto DefibrillatorFCO · Traditional | 08/02/1995SE |
| K945043 | Battery Pack #PMX120-18AIZL · Traditional | 01/20/1995SE |
| K934508 | Battery Pack# S1024NCLDD · Traditional | 02/17/1994SE |
| K934439 | Rechargeable Battery Pack for Critikon 8100 Vital Signs MonitorDPS · Traditional | 02/17/1994SE |
| K934015 | Recharge Replace Battery PK Spacelabs 4045 Mon/DefibLDD · Traditional | 02/17/1994SE |
| K933065 | Battery Pack# S1009LADPS · Traditional | 02/17/1994SE |
| K932823 | Battery Pack# S1018LA for Ivac 4000, 4200 Vital CheckDXN · Traditional | 02/17/1994SE |
| K931484 | Replacement Batter for Abbott Labs Lifecare 4100 SBZD · Traditional | 02/17/1994SE |
| K931483 | Replacement Batery for GE AMX-4 Port. X-Ray Mach.IZL · Traditional | 02/17/1994SE |
Questions and answers
When was Battery Pack 1017LA cleared by the FDA?
Battery Pack 1017LA (K931716) received a 510(k) decision of Substantially Equivalent on February 7, 1994, 307 days after the submission was received.
What is the product code of K931716?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.