Recharge Replace Battery PK Spacelabs 4045 Mon/Defib
FDA 510(k) K934015 · Portable Power Systems, Inc.
510(k) numberK934015
Submission
- Device name
- Recharge Replace Battery PK Spacelabs 4045 Mon/Defib
- Applicant
- Portable Power Systems, Inc.
Parker, CO, US - Received
- August 17, 1993
- Decision date
- February 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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More from Zoll Medical Corporation, World Wide Headquarters
| 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 |
| 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 |
| K931348 | Battery Pack #1005NCBTA · Traditional | 02/17/1994SE |
Questions and answers
When was Recharge Replace Battery PK Spacelabs 4045 Mon/Defib cleared by the FDA?
Recharge Replace Battery PK Spacelabs 4045 Mon/Defib (K934015) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 184 days after the submission was received.
What is the product code of K934015?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.