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FDA 510(k)

FLEXLAB 3.6, ACCELERATOR A3600

K-Number: K121012 · 2012-08-31

ApplicantInpeco S.P.A.
Decision Date2012-08-31
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLEXLAB 3.6, ACCELERATOR A3600 is the device name listed in this FDA 510(k) record. The listed applicant is Inpeco S.P.A.. It received FDA 510(k) clearance on 2012-08-31 under 510(k) number K121012. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXLAB 3.6, ACCELERATOR A3600?

FLEXLAB 3.6, ACCELERATOR A3600 is a medical device that received FDA 510(k) clearance on 2012-08-31. The listed applicant is Inpeco S.P.A.. The 510(k) number is K121012.

When did FLEXLAB 3.6, ACCELERATOR A3600 receive FDA 510(k) clearance?

FLEXLAB 3.6, ACCELERATOR A3600 received FDA 510(k) clearance on 2012-08-31, under 510(k) number K121012.

Who is the listed applicant for FLEXLAB 3.6, ACCELERATOR A3600?

The FDA 510(k) record lists Inpeco S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXLAB 3.6, ACCELERATOR A3600?

The FDA product code for FLEXLAB 3.6, ACCELERATOR A3600 is CEM.

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Related Devices (Code: CEM)

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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