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FDA 510(k)

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000

K-Number: K853149 · 1985-09-05

Decision Date1985-09-05
Product CodeHME
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is F. & F. Koenigkramer. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K853149. The device is classified under product code HME. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELIANCE 1000, RELIANCE 1500, RELIANCE 2000?

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is F. & F. Koenigkramer. The 510(k) number is K853149.

When did RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 receive FDA 510(k) clearance?

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 received FDA 510(k) clearance on 1985-09-05, under 510(k) number K853149.

Who is the listed applicant for RELIANCE 1000, RELIANCE 1500, RELIANCE 2000?

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

What is the FDA product code for RELIANCE 1000, RELIANCE 1500, RELIANCE 2000?

The FDA product code for RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 is HME.

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 F. & F. Koenigkramer 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.

View all 9 devices →

Related Devices (Code: HME)

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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