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FDA 510(k)

AME PINSITE SHIELD(TM)

K-Number: K884798 · 1989-02-10

ApplicantAmerican Medical Electronics, Inc.
Decision Date1989-02-10
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AME PINSITE SHIELD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Electronics, Inc.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K884798. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AME PINSITE SHIELD(TM)?

AME PINSITE SHIELD(TM) is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K884798.

When did AME PINSITE SHIELD(TM) receive FDA 510(k) clearance?

AME PINSITE SHIELD(TM) received FDA 510(k) clearance on 1989-02-10, under 510(k) number K884798.

Who is the listed applicant for AME PINSITE SHIELD(TM)?

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

What is the FDA product code for AME PINSITE SHIELD(TM)?

The FDA product code for AME PINSITE SHIELD(TM) is JEC.

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Other records listing American Medical Electronics, Inc. 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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