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)

CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER

K-Number: K891997 · 1989-06-08

ApplicantCorometrics Medical Systems, Inc.
Decision Date1989-06-08
Product CodeHFM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Corometrics Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-06-08 under 510(k) number K891997. The device is classified under product code HFM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER?

CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Corometrics Medical Systems, Inc.. The 510(k) number is K891997.

When did CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER receive FDA 510(k) clearance?

CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER received FDA 510(k) clearance on 1989-06-08, under 510(k) number K891997.

Who is the listed applicant for CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER?

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

What is the FDA product code for CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER?

The FDA product code for CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER is HFM.

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 Corometrics Medical Systems, 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.

K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERK905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERK903623MODEL600 UTERINE ACTIVITY MONITORK880900SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER

Related Devices (Code: HFM)

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.

K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.K013477TOCO LITE, MODEL TD-01Ventrex, Inc.K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, 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.

↑