Physio Control Lifepak 200 Auto Defibrillator
FDA 510(k) K946080 · Portable Power Systems, Inc.
510(k) numberK946080
Submission
- Device name
- Physio Control Lifepak 200 Auto Defibrillator
- Applicant
- Portable Power Systems, Inc.
Castle Rock, CO, US - Received
- December 13, 1994
- Decision date
- August 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FCO – Box, Battery, Rechargeable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945870 | R&D Part Nos. 5490, 5541, 5358, 5497FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944389 | R&D Batteries Part Nos. 5111, 5112, 5065, 5153FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944388 | R&D Batteries Part Nos. 5116, 5124, 5099, 5100FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944348 | R&D Batteries, Inc. Part No. 5128, 5053, 5007FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K945868 | R&D Part Nos. 5262, 5543, 5432, 5469FCO · Traditional | R & D Batteries, Inc. | 03/06/1995SE |
| K944521 | Rechargeable BatteriesFCO · Traditional | R & D Batteries, Inc. | 03/06/1995SE |
| K944387 | R&D Batteries Part Nos. 5186 and 5230FCO · Traditional | R & D Batteries, Inc. | 03/02/1995SE |
| K945871 | R&D Part Nos. 5339, 5510, 5514FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
| K945869 | R&D Part Nos. 5443, 5322, 5448, 5492FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
| K944390 | R&D Batteries Part Nos. 5141, 5067, 5118, 5277FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
More from R & D Batteries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970234 | Sealed Lead Acid Battery PackIZL · Traditional | 05/02/1997SE |
| 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 |
| K931348 | Battery Pack #1005NCBTA · Traditional | 02/17/1994SE |
Questions and answers
When was Physio Control Lifepak 200 Auto Defibrillator cleared by the FDA?
Physio Control Lifepak 200 Auto Defibrillator (K946080) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 232 days after the submission was received.
What is the product code of K946080?
The FDA product code is FCO – Box, Battery, Rechargeable, a Class I (low risk) device regulated under 21 CFR 876.1500.