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FDA 510(k)

ZYMED MODEL 1610

K-Number: K895208 · 1989-12-12

ApplicantAgilent Technologies
Decision Date1989-12-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZYMED MODEL 1610 is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies. It received FDA 510(k) clearance on 1989-12-12 under 510(k) number K895208. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYMED MODEL 1610?

ZYMED MODEL 1610 is a medical device that received FDA 510(k) clearance on 1989-12-12. The listed applicant is Agilent Technologies. The 510(k) number is K895208.

When did ZYMED MODEL 1610 receive FDA 510(k) clearance?

ZYMED MODEL 1610 received FDA 510(k) clearance on 1989-12-12, under 510(k) number K895208.

Who is the listed applicant for ZYMED MODEL 1610?

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

What is the FDA product code for ZYMED MODEL 1610?

The FDA product code for ZYMED MODEL 1610 is DSI.

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Other records listing Agilent Technologies 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: DSI)

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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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