FDA 510(k)

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM

K-Number: K050575 · 2005-08-15

Decision Date2005-08-15

Product CodeMDM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Futumeds Sdn Bhd. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K050575. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM?

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is Futumeds Sdn Bhd. The 510(k) number is K050575.

When did FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM receive FDA 510(k) clearance?

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM received FDA 510(k) clearance on 2005-08-15, under 510(k) number K050575.

Who is the listed applicant for FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM?

The FDA 510(k) record lists Futumeds Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM?

The FDA product code for FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM is MDM.

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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.