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510(k) K941813

VENSHIELD by Cybermedic, Inc. — Product Code BYD

K941813 is an FDA 510(k) premarket notification submitted by Cybermedic, Inc. for the device "VENSHIELD". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Cybermedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
April 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
Review Panel
AN
Submission Type

Other clearances by Cybermedic, Inc.

  • K914205 — PFF-1 (May 1, 1992)
  • K903959 — NEONATAL METASCOPE (November 23, 1990)
  • K884910 — MODEL 1010, CY-MET (June 12, 1989)
  • K861418 — SPINNAKER (May 9, 1986)
  • K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (July 8, 1985)
  • K842782 — PHYSIOLOGICAL ANALYZER CM-710 (August 17, 1984)
  • K842760 — LUNG ANALYZER CM-310 (July 26, 1984)
  • K831586 — CM-VII PHYSIOLOGIC ANALYZER (March 19, 1984)
  • K800547 — MEDISTOR III LUNG ANALYZER (March 25, 1980)
  • K790579 — MEDISTOR II (April 4, 1979)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)

FDA data resources