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510(k) K843591

INTERCEPT by Vital Signs, Inc. — Product Code KDP

K843591 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "INTERCEPT". The FDA issued a decision of Substantially Equivalent on October 19, 1984. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
September 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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)

Other clearances for product code KDP

  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)
  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)

FDA data resources