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 PACKS (OTHER THAN CV)

K-Number: K881885 · 1988-07-26

ApplicantDowit Service Co., Inc.
Decision Date1988-07-26
Product CodeFCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BATTERY PACKS (OTHER THAN CV) is the device name listed in this FDA 510(k) record. The listed applicant is Dowit Service Co., Inc.. It received FDA 510(k) clearance on 1988-07-26 under 510(k) number K881885. The device is classified under product code FCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATTERY PACKS (OTHER THAN CV)?

BATTERY PACKS (OTHER THAN CV) is a medical device that received FDA 510(k) clearance on 1988-07-26. The listed applicant is Dowit Service Co., Inc.. The 510(k) number is K881885.

When did BATTERY PACKS (OTHER THAN CV) receive FDA 510(k) clearance?

BATTERY PACKS (OTHER THAN CV) received FDA 510(k) clearance on 1988-07-26, under 510(k) number K881885.

Who is the listed applicant for BATTERY PACKS (OTHER THAN CV)?

The FDA 510(k) record lists Dowit Service Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BATTERY PACKS (OTHER THAN CV)?

The FDA product code for BATTERY PACKS (OTHER THAN CV) is FCP.

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 Dowit Service Co., 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.

K881643BATTERY PACKS FOR CARDIOVASCULAR UNITS

Related Devices (Code: FCP)

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.

K891927TELEMETRY POWER PACK MODEL 2Lucas & Rhea Mfg.

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.

↑