Ventilatory Frequency Monitor

FDA 510(k) K834569 · Cryo Corp.

Substantially Equivalent

510(k) numberK834569

Submission

Device name
Ventilatory Frequency Monitor
Applicant
Cryo Corp.
Mchenry, IL, US
Received
December 29, 1983
Decision date
March 30, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZO – Set, Tubing And Support, Ventilator (W Harness)
Device class
Class I (low risk)
Regulation
21 CFR 868.5975
Specialty
Anesthesiology

Other 510(k)s with product code BZO

510(k)DeviceApplicantDecision
K953784Unicor, Inc. Corrugated TubingBZO · Traditional Unicor, Inc.09/19/1995SE
K953785Unicor, Inc. Ventilator HosesBZO · Traditional Unicor, Inc.09/18/1995SE
K952022Prima Volumn VentilatorssBZO · Traditional Prima, Inc.05/22/1995SE
K952012Prima Custom Anestesia CircuitBZO · Traditional Prima, Inc.05/22/1995SE
K952011Prima Breathing BagsBZO · Traditional Prima, Inc.05/22/1995SE
K952010Prima Ventilator HosesBZO · Traditional Prima, Inc.05/22/1995SE
K945740Infant Flow SystemBZO · Traditional Hamilton Medical, Inc.03/23/1995SE
K944531Prima, Inc. Corrugated TubingBZO · Traditional Prima, Inc.12/02/1994SE
K942572Volume VentilatorBZO · Traditional Med-Plastics Intl., Inc.06/10/1994SE
K942569Ventilator HoseBZO · Traditional Med-Plastics Intl., Inc.06/10/1994SE

More from Med-Plastics Intl., Inc.

510(k)DeviceDecision
K872145Cellsoft(Tm)-Casa (Series 1000,2000 & 3000)GKL · Traditional 11/13/1987SE
K833994Pulsair I & IIBYJ · Traditional 12/12/1983SE

Questions and answers

When was Ventilatory Frequency Monitor cleared by the FDA?

Ventilatory Frequency Monitor (K834569) received a 510(k) decision of Substantially Equivalent on March 30, 1984, 92 days after the submission was received.

What is the product code of K834569?

The FDA product code is BZO – Set, Tubing And Support, Ventilator (W Harness), a Class I (low risk) device regulated under 21 CFR 868.5975.