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FDA 510(k)

DWFritz ASM2000

K-Number: K213894 · 2022-03-14

ApplicantDwfritz Automation, Inc.
Decision Date2022-03-14
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DWFritz ASM2000 is the device name listed in this FDA 510(k) record. The listed applicant is Dwfritz Automation, Inc.. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K213894. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DWFritz ASM2000?

DWFritz ASM2000 is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Dwfritz Automation, Inc.. The 510(k) number is K213894.

When did DWFritz ASM2000 receive FDA 510(k) clearance?

DWFritz ASM2000 received FDA 510(k) clearance on 2022-03-14, under 510(k) number K213894.

Who is the listed applicant for DWFritz ASM2000?

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

What is the FDA product code for DWFritz ASM2000?

The FDA product code for DWFritz ASM2000 is FXX.

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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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