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FDA 510(k)

CALIPER-OPTHALMIC

K-Number: K813315 · 1982-03-01

ApplicantDesign Research Assoc., Inc.
Decision Date1982-03-01
Product CodeHOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CALIPER-OPTHALMIC is the device name listed in this FDA 510(k) record. The listed applicant is Design Research Assoc., Inc.. It received FDA 510(k) clearance on 1982-03-01 under 510(k) number K813315. The device is classified under product code HOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIPER-OPTHALMIC?

CALIPER-OPTHALMIC is a medical device that received FDA 510(k) clearance on 1982-03-01. The listed applicant is Design Research Assoc., Inc.. The 510(k) number is K813315.

When did CALIPER-OPTHALMIC receive FDA 510(k) clearance?

CALIPER-OPTHALMIC received FDA 510(k) clearance on 1982-03-01, under 510(k) number K813315.

Who is the listed applicant for CALIPER-OPTHALMIC?

The FDA 510(k) record lists Design Research Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIPER-OPTHALMIC?

The FDA product code for CALIPER-OPTHALMIC is HOE.

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Other records listing Design Research Assoc., Inc. 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.

K813313BIOMICROSCOPY CONTACT LENSK813314NLD IMPLANT SET

Related Devices (Code: HOE)

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.

K881094KOI(TM) BLADE GAUGE, MODEL KOI-132CooperVision, Inc.K820050KREMER BLADE GAUGEAccutome, Inc.K812011BLADE GAUGEKoi, Inc.K801937BLEPHAROMETERAztec Medical Products, Inc.K792383KELMAN DIPSTICKV. Mueller O.V. Baxter Healthcare Corp.K781715RULER, WECK SCOTTEdward Weck, Inc.

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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