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FDA 510(k)

DECOMAT A 8666

K-Number: K920413 · 1994-04-05

ApplicantGetinge International, Inc.
Decision Date1994-04-05
Product CodeMDZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DECOMAT A 8666 is the device name listed in this FDA 510(k) record. The listed applicant is Getinge International, Inc.. It received FDA 510(k) clearance on 1994-04-05 under 510(k) number K920413. The device is classified under product code MDZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECOMAT A 8666?

DECOMAT A 8666 is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Getinge International, Inc.. The 510(k) number is K920413.

When did DECOMAT A 8666 receive FDA 510(k) clearance?

DECOMAT A 8666 received FDA 510(k) clearance on 1994-04-05, under 510(k) number K920413.

Who is the listed applicant for DECOMAT A 8666?

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

What is the FDA product code for DECOMAT A 8666?

The FDA product code for DECOMAT A 8666 is MDZ.

Related Clinical Trials

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Other records listing Getinge International, 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.

K920406DECOMAT 228K821842GAS STERILIZATION EQUIPMENTK821591STEAM STERILIZATION EQUIPMENT

Related Devices (Code: MDZ)

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.

K920406DECOMAT 228Getinge International, Inc.

Official Source

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