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FDA 510(k)

BABYLANCE HEEL INCISION DEVICE

K-Number: K130132 · 2013-02-11

ApplicantMedipurpose Pte. , Ltd.
Decision Date2013-02-11
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BABYLANCE HEEL INCISION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medipurpose Pte. , Ltd.. It received FDA 510(k) clearance on 2013-02-11 under 510(k) number K130132. 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 BABYLANCE HEEL INCISION DEVICE?

BABYLANCE HEEL INCISION DEVICE is a medical device that received FDA 510(k) clearance on 2013-02-11. The listed applicant is Medipurpose Pte. , Ltd.. The 510(k) number is K130132.

When did BABYLANCE HEEL INCISION DEVICE receive FDA 510(k) clearance?

BABYLANCE HEEL INCISION DEVICE received FDA 510(k) clearance on 2013-02-11, under 510(k) number K130132.

Who is the listed applicant for BABYLANCE HEEL INCISION DEVICE?

The FDA 510(k) record lists Medipurpose Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABYLANCE HEEL INCISION DEVICE?

The FDA product code for BABYLANCE HEEL INCISION DEVICE is FMK.

Related Clinical Trials

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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Other records listing Medipurpose Pte. , Ltd. as applicant

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.

K222224SurgiLance® Safety LancetK110062MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AGK101145SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250K101417BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200

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.

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