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FDA 510(k)

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM

K-Number: K852608 · 1985-09-27

ApplicantGe Medical Systems Information Technologies
Decision Date1985-09-27
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K852608. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM?

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K852608.

When did SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM receive FDA 510(k) clearance?

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM received FDA 510(k) clearance on 1985-09-27, under 510(k) number K852608.

Who is the listed applicant for SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM?

The FDA product code for SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM is HGM.

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Other records listing Ge Medical Systems Information Technologies as applicant

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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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