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)

GOULD MODEL IM3000-IM3100 BATTERY POWER

K-Number: K830885 · 1983-06-22

ApplicantGould, Inc.
Decision Date1983-06-22
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GOULD MODEL IM3000-IM3100 BATTERY POWER is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K830885. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOULD MODEL IM3000-IM3100 BATTERY POWER?

GOULD MODEL IM3000-IM3100 BATTERY POWER is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Gould, Inc.. The 510(k) number is K830885.

When did GOULD MODEL IM3000-IM3100 BATTERY POWER receive FDA 510(k) clearance?

GOULD MODEL IM3000-IM3100 BATTERY POWER received FDA 510(k) clearance on 1983-06-22, under 510(k) number K830885.

Who is the listed applicant for GOULD MODEL IM3000-IM3100 BATTERY POWER?

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

What is the FDA product code for GOULD MODEL IM3000-IM3100 BATTERY POWER?

The FDA product code for GOULD MODEL IM3000-IM3100 BATTERY POWER is DRT.

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 Gould, 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

View all 31 devices →

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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.

↑