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FDA 510(k)

KEYMED SIGMOIDOSCOPE SUCTION UNIT

K-Number: K841822 · 1984-07-27

ApplicantKeymed, Inc.
Decision Date1984-07-27
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KEYMED SIGMOIDOSCOPE SUCTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1984-07-27 under 510(k) number K841822. 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 KEYMED SIGMOIDOSCOPE SUCTION UNIT?

KEYMED SIGMOIDOSCOPE SUCTION UNIT is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Keymed, Inc.. The 510(k) number is K841822.

When did KEYMED SIGMOIDOSCOPE SUCTION UNIT receive FDA 510(k) clearance?

KEYMED SIGMOIDOSCOPE SUCTION UNIT received FDA 510(k) clearance on 1984-07-27, under 510(k) number K841822.

Who is the listed applicant for KEYMED SIGMOIDOSCOPE SUCTION UNIT?

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

What is the FDA product code for KEYMED SIGMOIDOSCOPE SUCTION UNIT?

The FDA product code for KEYMED SIGMOIDOSCOPE SUCTION UNIT is DRM.

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Other records listing Keymed, Inc. 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.

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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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