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FDA 510(k)

PRESSURE GAUGE

K-Number: K853040 · 1985-10-10

ApplicantErie Medical
Decision Date1985-10-10
Product CodeBXH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRESSURE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Erie Medical. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K853040. The device is classified under product code BXH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE GAUGE?

PRESSURE GAUGE is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Erie Medical. The 510(k) number is K853040.

When did PRESSURE GAUGE receive FDA 510(k) clearance?

PRESSURE GAUGE received FDA 510(k) clearance on 1985-10-10, under 510(k) number K853040.

Who is the listed applicant for PRESSURE GAUGE?

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

What is the FDA product code for PRESSURE GAUGE?

The FDA product code for PRESSURE GAUGE is BXH.

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.

Other records listing Erie Medical 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.

Related Devices (Code: BXH)

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.

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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