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FDA 510(k)

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30

K-Number: K872596 · 1987-09-30

Decision Date1987-09-30
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K872596. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30?

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is American Edwards Laboratories. The 510(k) number is K872596.

When did TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 receive FDA 510(k) clearance?

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 received FDA 510(k) clearance on 1987-09-30, under 510(k) number K872596.

Who is the listed applicant for TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30?

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

What is the FDA product code for TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30?

The FDA product code for TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 is DRS.

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Other records listing American Edwards Laboratories 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: DRS)

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.

Official Source

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