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510(k) K812737

RAIN-X by Nova-Ventrx — Product Code BZO

K812737 is an FDA 510(k) premarket notification submitted by Nova-Ventrx for the device "RAIN-X". The FDA issued a decision of Substantially Equivalent on October 23, 1981. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Nova-Ventrx has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1981
Date Received
September 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type

Other clearances by Nova-Ventrx

  • K952267 — CRITERION, CRITERION I.V., MODIFIED (December 2, 1997)
  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K893760 — CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (August 10, 1989)
  • K881207 — RES-Q 1, 2, 3, 4 AND 5 (August 15, 1988)
  • K870382 — DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 (March 6, 1987)
  • K863756 — MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (November 13, 1986)
  • K850600 — CO-AX VENTILATOR CIRCUIT (May 2, 1985)
  • K842794 — MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 (October 4, 1984)
  • K842795 — MAXI-MISER HUMIDIFIER INSERT 1030 (October 4, 1984)
  • K841569 — MAXI-MISER HUMIDIFIER INSERT 1020 (May 30, 1984)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources