Atlas FDA

DISPOSABLE LARYNGOSCOPE

FDA 510(k) clearance K850437 · decided 1985-02-14

Clearance details

K-number
K850437
Device name
DISPOSABLE LARYNGOSCOPE
Applicant
Vital Signs, Inc.
Decision
Substantially Equivalent
Date received
1985-02-05
Decision date
1985-02-14
Days to decision
9 days
Clearance type
Traditional
Product code
LLW
Device class
2
Regulation number
884.4550
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Totowa, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.