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FDA 510(k)

HOSPITAL SPACER

K-Number: K032809 · 2003-11-13

ApplicantRespironics Healthscan, Inc.
Decision Date2003-11-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HOSPITAL SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Healthscan, Inc.. It received FDA 510(k) clearance on 2003-11-13 under 510(k) number K032809. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOSPITAL SPACER?

HOSPITAL SPACER is a medical device that received FDA 510(k) clearance on 2003-11-13. The listed applicant is Respironics Healthscan, Inc.. The 510(k) number is K032809.

When did HOSPITAL SPACER receive FDA 510(k) clearance?

HOSPITAL SPACER received FDA 510(k) clearance on 2003-11-13, under 510(k) number K032809.

Who is the listed applicant for HOSPITAL SPACER?

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

What is the FDA product code for HOSPITAL SPACER?

The FDA product code for HOSPITAL SPACER is CAF.

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Other records listing Respironics Healthscan, 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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Related Devices (Code: CAF)

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Official Source

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