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FDA 510(k)

DECOMAT 228

K-Number: K920406 · 1994-04-05

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

Device Summary

DECOMAT 228 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 K920406. 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 228?

DECOMAT 228 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 K920406.

When did DECOMAT 228 receive FDA 510(k) clearance?

DECOMAT 228 received FDA 510(k) clearance on 1994-04-05, under 510(k) number K920406.

Who is the listed applicant for DECOMAT 228?

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 228?

The FDA product code for DECOMAT 228 is MDZ.

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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.

K920413DECOMAT A 8666K821842GAS 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.

K920413DECOMAT A 8666Getinge International, Inc.

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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