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FDA 510(k)

ELMED PNEUMOMAT DIGITAL

K-Number: K905417 · 1991-01-31

ApplicantElmed, Inc.
Decision Date1991-01-31
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELMED PNEUMOMAT DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1991-01-31 under 510(k) number K905417. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELMED PNEUMOMAT DIGITAL?

ELMED PNEUMOMAT DIGITAL is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Elmed, Inc.. The 510(k) number is K905417.

When did ELMED PNEUMOMAT DIGITAL receive FDA 510(k) clearance?

ELMED PNEUMOMAT DIGITAL received FDA 510(k) clearance on 1991-01-31, under 510(k) number K905417.

Who is the listed applicant for ELMED PNEUMOMAT DIGITAL?

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

What is the FDA product code for ELMED PNEUMOMAT DIGITAL?

The FDA product code for ELMED PNEUMOMAT DIGITAL is HIF.

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Other records listing Elmed, 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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Related Devices (Code: HIF)

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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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.

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