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FDA 510(k)

ESA CAMERA

K-Number: K823516 · 1982-12-30

ApplicantConcept, Inc.
Decision Date1982-12-30
Product CodeFWH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823516. The device is classified under product code FWH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESA CAMERA?

ESA CAMERA is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Concept, Inc.. The 510(k) number is K823516.

When did ESA CAMERA receive FDA 510(k) clearance?

ESA CAMERA received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823516.

Who is the listed applicant for ESA CAMERA?

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

What is the FDA product code for ESA CAMERA?

The FDA product code for ESA CAMERA is FWH.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: FWH)

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.

K884039MEDICAL DYNAMICS SOLID STATE VIDEO CAMERA 5940Medical Dynamics, 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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