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FDA 510(k)

SOFTTOUCH II LANCET DEVICE

K-Number: K931258 · 1994-02-10

ApplicantBoehringer Mannheim Corp.
Decision Date1994-02-10
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTTOUCH II LANCET DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K931258. 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 SOFTTOUCH II LANCET DEVICE?

SOFTTOUCH II LANCET DEVICE is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K931258.

When did SOFTTOUCH II LANCET DEVICE receive FDA 510(k) clearance?

SOFTTOUCH II LANCET DEVICE received FDA 510(k) clearance on 1994-02-10, under 510(k) number K931258.

Who is the listed applicant for SOFTTOUCH II LANCET DEVICE?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTTOUCH II LANCET DEVICE?

The FDA product code for SOFTTOUCH II LANCET DEVICE is FMK.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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

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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