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FDA 510(k)

MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE

K-Number: K854734 · 1986-02-10

ApplicantMedasonics, Inc.
Decision Date1986-02-10
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE is the device name listed in this FDA 510(k) record. The listed applicant is Medasonics, Inc.. It received FDA 510(k) clearance on 1986-02-10 under 510(k) number K854734. 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 MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE?

MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE is a medical device that received FDA 510(k) clearance on 1986-02-10. The listed applicant is Medasonics, Inc.. The 510(k) number is K854734.

When did MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE receive FDA 510(k) clearance?

MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE received FDA 510(k) clearance on 1986-02-10, under 510(k) number K854734.

Who is the listed applicant for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE?

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

What is the FDA product code for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE?

The FDA product code for MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE is DRM.

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Other records listing Medasonics, Inc. as applicant

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Related Devices (Code: DRM)

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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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