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FDA 510(k)

BABY LIGHT DOSIMETER

K-Number: K832298 · 1983-10-19

ApplicantRocky Mountain Medical Corp.
Decision Date1983-10-19
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BABY LIGHT DOSIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Rocky Mountain Medical Corp.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832298. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABY LIGHT DOSIMETER?

BABY LIGHT DOSIMETER is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Rocky Mountain Medical Corp.. The 510(k) number is K832298.

When did BABY LIGHT DOSIMETER receive FDA 510(k) clearance?

BABY LIGHT DOSIMETER received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832298.

Who is the listed applicant for BABY LIGHT DOSIMETER?

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

What is the FDA product code for BABY LIGHT DOSIMETER?

The FDA product code for BABY LIGHT DOSIMETER is LBI.

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Other records listing Rocky Mountain Medical 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.

K890202TELE-TEMP THERMOMETERK860120NURSERY AMBIENT LIGHT METERK852167ISOVOL-EXCHANGE TRAYK853970ALPHA CHUCKK853790BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCERK851876PREFER INCONTINENCE AID

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Related Devices (Code: LBI)

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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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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