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FDA 510(k)

CHRYS(TM) MODEL MED-MAX

K-Number: K875338 · 1988-04-13

ApplicantCalifornia Laboratories, Inc.
Decision Date1988-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHRYS(TM) MODEL MED-MAX is the device name listed in this FDA 510(k) record. The listed applicant is California Laboratories, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K875338. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHRYS(TM) MODEL MED-MAX?

CHRYS(TM) MODEL MED-MAX is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is California Laboratories, Inc.. The 510(k) number is K875338.

When did CHRYS(TM) MODEL MED-MAX receive FDA 510(k) clearance?

CHRYS(TM) MODEL MED-MAX received FDA 510(k) clearance on 1988-04-13, under 510(k) number K875338.

Who is the listed applicant for CHRYS(TM) MODEL MED-MAX?

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

What is the FDA product code for CHRYS(TM) MODEL MED-MAX?

The FDA product code for CHRYS(TM) MODEL MED-MAX is GEX. This falls under the Gastroenterology category.

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Official Source

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