FDA 510(k)

PALS

K-Number: K863621 · 1986-10-06

Decision Date1986-10-06

Product CodeFMK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PALS is the device name listed in this FDA 510(k) record. The listed applicant is West Lake Marketing. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K863621. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALS?

PALS is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is West Lake Marketing. The 510(k) number is K863621.

When did PALS receive FDA 510(k) clearance?

PALS received FDA 510(k) clearance on 1986-10-06, under 510(k) number K863621.

Who is the listed applicant for PALS?

The FDA 510(k) record lists West Lake Marketing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALS?

The FDA product code for PALS is FMK.

Related Devices (Code: FMK)

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.

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.