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510(k) K850437

DISPOSABLE LARYNGOSCOPE by Vital Signs, Inc. — Product Code LLW

K850437 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "DISPOSABLE LARYNGOSCOPE". The FDA issued a decision of Substantially Equivalent on February 14, 1985. The device falls under product code LLW (Laser, Neodymium:Yag For Gynecologic Use), a Class II device regulated under 21 CFR 884.4550. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
February 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag For Gynecologic Use
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)

FDA data resources