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FDA 510(k)

ZIPPREP ELECTRODE

K-Number: K940802 · 1994-06-22

ApplicantAspect Medical Systems, Inc.
Decision Date1994-06-22
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZIPPREP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Aspect Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-06-22 under 510(k) number K940802. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIPPREP ELECTRODE?

ZIPPREP ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Aspect Medical Systems, Inc.. The 510(k) number is K940802.

When did ZIPPREP ELECTRODE receive FDA 510(k) clearance?

ZIPPREP ELECTRODE received FDA 510(k) clearance on 1994-06-22, under 510(k) number K940802.

Who is the listed applicant for ZIPPREP ELECTRODE?

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

What is the FDA product code for ZIPPREP ELECTRODE?

The FDA product code for ZIPPREP ELECTRODE is DRX.

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Other records listing Aspect 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.

K093183BIS QUATRO SENSORK091854BIS CLICK SENSOR/CABLEK072286BIS EEG VISTA MONITOR SYSTEM AND BISXK062613BIS EEG MONITOR VIEWK070069ZIPPREP ELECTRODEK062692BIS BILATERAL SENSOR

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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