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FDA 510(k)

RESPICORD

K-Number: K821998 · 1982-07-30

ApplicantNovamed Products, Inc.
Decision Date1982-07-30
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPICORD is the device name listed in this FDA 510(k) record. The listed applicant is Novamed Products, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821998. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPICORD?

RESPICORD is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Novamed Products, Inc.. The 510(k) number is K821998.

When did RESPICORD receive FDA 510(k) clearance?

RESPICORD received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821998.

Who is the listed applicant for RESPICORD?

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

What is the FDA product code for RESPICORD?

The FDA product code for RESPICORD is BWF.

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Other records listing Novamed Products, 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.

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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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