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FDA 510(k)

HLA-2000

K-Number: K790513 · 1979-05-31

ApplicantBdt Ent.
Decision Date1979-05-31
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HLA-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Bdt Ent.. It received FDA 510(k) clearance on 1979-05-31 under 510(k) number K790513. 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 HLA-2000?

HLA-2000 is a medical device that received FDA 510(k) clearance on 1979-05-31. The listed applicant is Bdt Ent.. The 510(k) number is K790513.

When did HLA-2000 receive FDA 510(k) clearance?

HLA-2000 received FDA 510(k) clearance on 1979-05-31, under 510(k) number K790513.

Who is the listed applicant for HLA-2000?

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

What is the FDA product code for HLA-2000?

The FDA product code for HLA-2000 is DRM.

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

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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