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FDA 510(k)

AIR-FLEX WITH AUTO-DISTRACTION

K-Number: K063034 · 2006-12-14

ApplicantHill Laboratories Co.
Decision Date2006-12-14
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIR-FLEX WITH AUTO-DISTRACTION is the device name listed in this FDA 510(k) record. The listed applicant is Hill Laboratories Co.. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K063034. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR-FLEX WITH AUTO-DISTRACTION?

AIR-FLEX WITH AUTO-DISTRACTION is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Hill Laboratories Co.. The 510(k) number is K063034.

When did AIR-FLEX WITH AUTO-DISTRACTION receive FDA 510(k) clearance?

AIR-FLEX WITH AUTO-DISTRACTION received FDA 510(k) clearance on 2006-12-14, under 510(k) number K063034.

Who is the listed applicant for AIR-FLEX WITH AUTO-DISTRACTION?

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

What is the FDA product code for AIR-FLEX WITH AUTO-DISTRACTION?

The FDA product code for AIR-FLEX WITH AUTO-DISTRACTION is JFB.

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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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