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FDA 510(k)

RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT

K-Number: K964338 · 1997-01-09

ApplicantRudolf Riester GmbH & Co. KG
Decision Date1997-01-09
Product CodeHKM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH & Co. KG. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964338. The device is classified under product code HKM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT?

RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K964338.

When did RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT receive FDA 510(k) clearance?

RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964338.

Who is the listed applicant for RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT?

The FDA 510(k) record lists Rudolf Riester GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT?

The FDA product code for RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT is HKM.

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Other records listing Rudolf Riester GmbH & Co. KG as applicant

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K002954RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERSK002955EMPIRE N BLOOD PRESSURE MANOMETERSK972377RI-MEGAK972378SANAPHON NK972379PRECISA NK972301BIG BEN SQUARE, BIG BEN ROUND

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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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