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FDA 510(k)

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER

K-Number: K982651 · 1998-12-11

ApplicantCorometrics Medical Systems, Inc.
Decision Date1998-12-11
Product CodeHEL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER 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 1998-12-11 under 510(k) number K982651. The device is classified under product code HEL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER?

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Corometrics Medical Systems, Inc.. The 510(k) number is K982651.

When did COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER receive FDA 510(k) clearance?

COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER received FDA 510(k) clearance on 1998-12-11, under 510(k) number K982651.

Who is the listed applicant for COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER?

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 COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER?

The FDA product code for COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER is HEL.

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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.

K905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERK903623MODEL600 UTERINE ACTIVITY MONITORK891997CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCERK880900SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER

Related Devices (Code: HEL)

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.

K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.K780035MINIVISORMetrix Teknika, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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