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FDA 510(k)

SEQUENCER

K-Number: K981313 · 1998-07-09

ApplicantImpac Medical Systems, Inc.
Decision Date1998-07-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SEQUENCER is the device name listed in this FDA 510(k) record. The listed applicant is Impac Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981313. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEQUENCER?

SEQUENCER is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Impac Medical Systems, Inc.. The 510(k) number is K981313.

When did SEQUENCER receive FDA 510(k) clearance?

SEQUENCER received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981313.

Who is the listed applicant for SEQUENCER?

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

What is the FDA product code for SEQUENCER?

The FDA product code for SEQUENCER is IYE.

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Other records listing Impac Medical Systems, 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.

K132971MONACOK123230MOSAIQ ONCOLOGY INFORMATION SYSTEMK120067MOSAIQ ONCOLOGY INFORMATION SYSTEMK043412MODIFICATION TO: VIEWSTATIONK013531QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00K011694VIEWSTATION

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Related Devices (Code: IYE)

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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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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