Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BATTERY PACK #PMX120-18A

K-Number: K945043 · 1995-01-20

ApplicantPortable Power Systems, Inc.
Decision Date1995-01-20
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BATTERY PACK #PMX120-18A is the device name listed in this FDA 510(k) record. The listed applicant is Portable Power Systems, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K945043. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATTERY PACK #PMX120-18A?

BATTERY PACK #PMX120-18A is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Portable Power Systems, Inc.. The 510(k) number is K945043.

When did BATTERY PACK #PMX120-18A receive FDA 510(k) clearance?

BATTERY PACK #PMX120-18A received FDA 510(k) clearance on 1995-01-20, under 510(k) number K945043.

Who is the listed applicant for BATTERY PACK #PMX120-18A?

The FDA 510(k) record lists Portable Power Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BATTERY PACK #PMX120-18A?

The FDA product code for BATTERY PACK #PMX120-18A is IZL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Portable Power Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970234SEALED LEAD ACID BATTERY PACKK946080PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATORK931483REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.K934508BATTERY PACK# S1024NCK934439RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITORK932823BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK

View all 18 devices →

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑