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FDA 510(k)

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

K-Number: K882517 · 1989-01-24

ApplicantRodenstock Instrument Corp.
Decision Date1989-01-24
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Rodenstock Instrument Corp.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K882517. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RODENSTOCK SCANNING LASER OPHTHALMOSCOPE?

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Rodenstock Instrument Corp.. The 510(k) number is K882517.

When did RODENSTOCK SCANNING LASER OPHTHALMOSCOPE receive FDA 510(k) clearance?

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE received FDA 510(k) clearance on 1989-01-24, under 510(k) number K882517.

Who is the listed applicant for RODENSTOCK SCANNING LASER OPHTHALMOSCOPE?

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

What is the FDA product code for RODENSTOCK SCANNING LASER OPHTHALMOSCOPE?

The FDA product code for RODENSTOCK SCANNING LASER OPHTHALMOSCOPE is HLI.

Related Clinical Trials

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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Other records listing Rodenstock Instrument Corp. 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.

K781440LENSOMETER MODEL 11

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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