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FDA 510(k)

BERGEN 710 ESU

K-Number: K945861 · 1995-03-01

ApplicantBergen Mfg.
Decision Date1995-03-01
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BERGEN 710 ESU is the device name listed in this FDA 510(k) record. The listed applicant is Bergen Mfg.. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K945861. The device is classified under product code HAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERGEN 710 ESU?

BERGEN 710 ESU is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Bergen Mfg.. The 510(k) number is K945861.

When did BERGEN 710 ESU receive FDA 510(k) clearance?

BERGEN 710 ESU received FDA 510(k) clearance on 1995-03-01, under 510(k) number K945861.

Who is the listed applicant for BERGEN 710 ESU?

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

What is the FDA product code for BERGEN 710 ESU?

The FDA product code for BERGEN 710 ESU is HAM.

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 Bergen Mfg. 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.

K972299BERGEN MODEL 500 ELECTROSURGERY GENERATORK964736BERGEN 610 BIPOLAR COAGULATORK863701MODEL 709 BIPOLAR MICRO COAGULATOR

Related Devices (Code: HAM)

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.

K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MNikomed U.S.A., Inc.K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.K913300LAPAROSTAT(TM)Cook Ob/GynK920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.K911353EMC MODEL NO. STATOME 900Emc Industries

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.

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