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)

BEAMER ONE

K-Number: K894663 · 1989-09-15

ApplicantBeacon Laboratories, Inc.
Decision Date1989-09-15
Product CodeHAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEAMER ONE is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K894663. 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 BEAMER ONE?

BEAMER ONE is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Beacon Laboratories, Inc.. The 510(k) number is K894663.

When did BEAMER ONE receive FDA 510(k) clearance?

BEAMER ONE received FDA 510(k) clearance on 1989-09-15, under 510(k) number K894663.

Who is the listed applicant for BEAMER ONE?

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

What is the FDA product code for BEAMER ONE?

The FDA product code for BEAMER ONE 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 Beacon Laboratories, 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.

K930243FLEXIBLE EXTENDERK930497ARGON HANDPIECESK925708DISPOSABLE ELECTROSURGERY BALL ELECTRODEK922289SESQUIPOLAR(TM) MIS ELECTRODEK925619DISPOSABLE HAND-SWITCHING ESU PENCILK915788MIS ELECTROSURGICAL ELECTRODES

View all 18 devices →

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.K945861BERGEN 710 ESUBergen Mfg.K913300LAPAROSTAT(TM)Cook Ob/GynK920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.

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.

↑