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FDA 510(k)

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES

K-Number: K971808 · 1997-09-26

ApplicantMonarch Medical
Decision Date1997-09-26
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Monarch Medical. It received FDA 510(k) clearance on 1997-09-26 under 510(k) number K971808. 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 SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES?

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-09-26. The listed applicant is Monarch Medical. The 510(k) number is K971808.

When did SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES receive FDA 510(k) clearance?

SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES received FDA 510(k) clearance on 1997-09-26, under 510(k) number K971808.

Who is the listed applicant for SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES?

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

What is the FDA product code for SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES?

The FDA product code for SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES is CAF.

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Related Devices (Code: CAF)

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Official Source

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