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)

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2

K-Number: K842754 · 1984-11-28

ApplicantCustom Ultrasonics
Decision Date1984-11-28
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 is the device name listed in this FDA 510(k) record. The listed applicant is Custom Ultrasonics. It received FDA 510(k) clearance on 1984-11-28 under 510(k) number K842754. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2?

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 is a medical device that received FDA 510(k) clearance on 1984-11-28. The listed applicant is Custom Ultrasonics. The 510(k) number is K842754.

When did CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 receive FDA 510(k) clearance?

CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 received FDA 510(k) clearance on 1984-11-28, under 510(k) number K842754.

Who is the listed applicant for CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2?

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

What is the FDA product code for CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2?

The FDA product code for CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 is FLG.

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 Custom Ultrasonics 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.

K122172SYSTEM 83 PLUSK061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORK983017MODIFICATION TO SYSTEM 83 PLUS

Related Devices (Code: FLG)

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.

K944950KLENZYMECalgon Corp.K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon Corp.

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.

↑