FDA 510(k)

SONICAID MODEL P110 FETAL HEAR DETECTOR

K-Number: K933816 · 1994-12-22

Decision Date1994-12-22

Product CodeHEL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SONICAID MODEL P110 FETAL HEAR DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments, Plc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K933816. 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 SONICAID MODEL P110 FETAL HEAR DETECTOR?

SONICAID MODEL P110 FETAL HEAR DETECTOR is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Oxford Instruments, Plc.. The 510(k) number is K933816.

When did SONICAID MODEL P110 FETAL HEAR DETECTOR receive FDA 510(k) clearance?

SONICAID MODEL P110 FETAL HEAR DETECTOR received FDA 510(k) clearance on 1994-12-22, under 510(k) number K933816.

Who is the listed applicant for SONICAID MODEL P110 FETAL HEAR DETECTOR?

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

What is the FDA product code for SONICAID MODEL P110 FETAL HEAR DETECTOR?

The FDA product code for SONICAID MODEL P110 FETAL HEAR DETECTOR is HEL.

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Other records listing Oxford Instruments, Plc. as applicant

K981405SYNERGY LT K961636MEDILOG VISION K961642MEDILOG MR95 K930714SONICAID MODEL TEAM FECG IUP

Related Devices (Code: HEL)

K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.K930714SONICAID MODEL TEAM FECG IUPOxford 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.