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FDA 510(k)

EPISENSOR

K-Number: K903224 · 1990-12-24

ApplicantPalex Intl. SA
Decision Date1990-12-24
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPISENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Palex Intl. SA. It received FDA 510(k) clearance on 1990-12-24 under 510(k) number K903224. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISENSOR?

EPISENSOR is a medical device that received FDA 510(k) clearance on 1990-12-24. The listed applicant is Palex Intl. SA. The 510(k) number is K903224.

When did EPISENSOR receive FDA 510(k) clearance?

EPISENSOR received FDA 510(k) clearance on 1990-12-24, under 510(k) number K903224.

Who is the listed applicant for EPISENSOR?

The FDA 510(k) record lists Palex Intl. SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPISENSOR?

The FDA product code for EPISENSOR is BSP.

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 Palex Intl. SA 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.

K905108CONTORNO(R), MODELS E AND STK904586PALEX IRRIGATION SETK902642CONTORNO (TM)K901680BAUMAN RIGID LARYNGOSCOPE

Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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