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FDA 510(k)

AUTOPULSE, MODEL 100

K-Number: K011046 · 2001-10-25

ApplicantRevivant Corp.
Decision Date2001-10-25
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOPULSE, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Revivant Corp.. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K011046. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPULSE, MODEL 100?

AUTOPULSE, MODEL 100 is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Revivant Corp.. The 510(k) number is K011046.

When did AUTOPULSE, MODEL 100 receive FDA 510(k) clearance?

AUTOPULSE, MODEL 100 received FDA 510(k) clearance on 2001-10-25, under 510(k) number K011046.

Who is the listed applicant for AUTOPULSE, MODEL 100?

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

What is the FDA product code for AUTOPULSE, MODEL 100?

The FDA product code for AUTOPULSE, MODEL 100 is DRM.

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 Revivant 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.

K040453AUTOPULSE RESUSCITATION SYSTEM, MODEL 100K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100K022345AUTOPULSE RESUSCITATION SYSTEM

Related Devices (Code: DRM)

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.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLCK173553LUCAS 3 Chest Compression SystemJolife ABK161768LUCAS 3 Chest Compression SystemJolife ABK153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLCK112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation

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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