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FDA 510(k)

TONOMITOR (TM) + SUMP

K-Number: K883234 · 1988-10-12

ApplicantTonometrics, Inc.
Decision Date1988-10-12
Product CodeFFT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TONOMITOR (TM) + SUMP is the device name listed in this FDA 510(k) record. The listed applicant is Tonometrics, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883234. The device is classified under product code FFT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONOMITOR (TM) + SUMP?

TONOMITOR (TM) + SUMP is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Tonometrics, Inc.. The 510(k) number is K883234.

When did TONOMITOR (TM) + SUMP receive FDA 510(k) clearance?

TONOMITOR (TM) + SUMP received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883234.

Who is the listed applicant for TONOMITOR (TM) + SUMP?

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

What is the FDA product code for TONOMITOR (TM) + SUMP?

The FDA product code for TONOMITOR (TM) + SUMP is FFT.

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 Tonometrics, 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.

K920849TRIP CIC CATHETERK911825TRIP(TM) NASOGASTRIC SUMP CATHETERK890466SIGMOID TONOMITOR

Related Devices (Code: FFT)

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.

K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBESandhill Scientific, Inc.K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc.K961346PH ANALYSIS MODULESynectics-DantecK950087LOT 440Medical Instruments Corporation Mic AGK955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium 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.

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