FDA 510(k)

IMD's Lumbar Puncture Needle

Numéro K : K170112 · 2018-02-02

DemandeurInternational Medical Development, Inc.(Imd)

Date de décision2018-02-02

Code produitBSP

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

IMD's Lumbar Puncture Needle is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Development, Inc.(Imd). It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K170112. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the IMD's Lumbar Puncture Needle?

IMD's Lumbar Puncture Needle is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is International Medical Development, Inc.(Imd). The 510(k) number is K170112.

When did IMD's Lumbar Puncture Needle receive FDA 510(k) clearance?

IMD's Lumbar Puncture Needle received FDA 510(k) clearance on 2018-02-02, under 510(k) number K170112.

Who is the listed applicant for IMD's Lumbar Puncture Needle?

The FDA 510(k) record lists International Medical Development, Inc.(Imd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMD's Lumbar Puncture Needle?

The FDA product code for IMD's Lumbar Puncture Needle is BSP.

Essais cliniques associés

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Dispositifs connexes (Code : BSP)

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

Source officielle

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