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FDA 510(k)

INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR

K-Number: K800179 · 1980-02-11

ApplicantSphygmetrics, Inc.
Decision Date1980-02-11
Product CodeDXW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sphygmetrics, Inc.. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K800179. The device is classified under product code DXW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR?

INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Sphygmetrics, Inc.. The 510(k) number is K800179.

When did INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR receive FDA 510(k) clearance?

INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800179.

Who is the listed applicant for INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR?

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

What is the FDA product code for INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR?

The FDA product code for INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR is DXW.

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.

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Other records listing Sphygmetrics, 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.

K800401INFRASONDE D4000 ELECTRONIC B-P MONITOR

Related Devices (Code: DXW)

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.

K972020OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITORCas Medical Systems, Inc.K955887NEWMED ABP-LITENewmed Corp.K802830MILLAR MIKRO-TIP CATHETER PHONOTRANSMillar Instruments, Inc.K800222MODEL 412 ELECTROFLUIDIC MANOMETERMed-Tek Corp.

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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