Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor
FDA 510(k) K934439 · Portable Power Systems, Inc.
510(k) numberK934439
Submission
- Device name
- Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor
- Applicant
- Portable Power Systems, Inc.
Parker, CO, US - Received
- August 23, 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
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
Other 510(k)s with product code DPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
More from Masimo 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 |
| 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 Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor cleared by the FDA?
Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor (K934439) received a 510(k) decision of Substantially Equivalent on February 17, 1994, 178 days after the submission was received.
What is the product code of K934439?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.