BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER— 510(k) K853790

Name: FDA 510(k) clearance K853790
Creator: U.S. Food and Drug Administration
Published: 1985-10-04

Substantially Equivalent

Rocky Mountain Medical Corp.

FDA 510(k) clearance K853790 for BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER, Substantially Equivalent on 1985-10-04. Applicant: Rocky Mountain Medical Corp.. Device class: 1.

Clearance details

Applicant: Rocky Mountain Medical Corp.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1985-09-10
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

More clearances from Rocky Mountain Medical Corp.

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K890202 — TELE-TEMP THERMOMETER1989-04-05
K860120 — NURSERY AMBIENT LIGHT METER1986-02-19
K852167 — ISOVOL-EXCHANGE TRAY1985-11-18
K853970 — ALPHA CHUCK1985-11-08
K851876 — PREFER INCONTINENCE AID1985-06-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.