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FDA 510(k)

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR

K-Number: K842323 · 1984-08-17

ApplicantAmerican Edwards Laboratories
Decision Date1984-08-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR 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 1984-08-17 under 510(k) number K842323. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. EDWARDS LAB FLEXISCOPE OBTURATOR?

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is American Edwards Laboratories. The 510(k) number is K842323.

When did AMER. EDWARDS LAB FLEXISCOPE OBTURATOR receive FDA 510(k) clearance?

AMER. EDWARDS LAB FLEXISCOPE OBTURATOR received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842323.

Who is the listed applicant for AMER. EDWARDS LAB FLEXISCOPE OBTURATOR?

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 AMER. EDWARDS LAB FLEXISCOPE OBTURATOR?

The FDA product code for AMER. EDWARDS LAB FLEXISCOPE OBTURATOR is HRX.

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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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