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FDA 510(k)

INFORMED REMOTE FIELD UNIT MODEL IFM1000

K-Number: K821712 · 1982-07-26

ApplicantBurditt & Calkins-Siemens-Elema
Decision Date1982-07-26
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFORMED REMOTE FIELD UNIT MODEL IFM1000 is the device name listed in this FDA 510(k) record. The listed applicant is Burditt & Calkins-Siemens-Elema. It received FDA 510(k) clearance on 1982-07-26 under 510(k) number K821712. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFORMED REMOTE FIELD UNIT MODEL IFM1000?

INFORMED REMOTE FIELD UNIT MODEL IFM1000 is a medical device that received FDA 510(k) clearance on 1982-07-26. The listed applicant is Burditt & Calkins-Siemens-Elema. The 510(k) number is K821712.

When did INFORMED REMOTE FIELD UNIT MODEL IFM1000 receive FDA 510(k) clearance?

INFORMED REMOTE FIELD UNIT MODEL IFM1000 received FDA 510(k) clearance on 1982-07-26, under 510(k) number K821712.

Who is the listed applicant for INFORMED REMOTE FIELD UNIT MODEL IFM1000?

The FDA 510(k) record lists Burditt & Calkins-Siemens-Elema as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFORMED REMOTE FIELD UNIT MODEL IFM1000?

The FDA product code for INFORMED REMOTE FIELD UNIT MODEL IFM1000 is BTY.

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Other records listing Burditt & Calkins-Siemens-Elema as applicant

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Related Devices (Code: BTY)

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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