Circuit, Intensive Care Ventilator
FDA 510(k) K760352 · Monaghan Medical Corp.
510(k) numberK760352
Submission
- Device name
- Circuit, Intensive Care Ventilator
- Applicant
- Monaghan Medical Corp.
Mchenry, IL, US - Received
- August 2, 1976
- Decision date
- August 11, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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Questions and answers
When was Circuit, Intensive Care Ventilator cleared by the FDA?
Circuit, Intensive Care Ventilator (K760352) received a 510(k) decision of Substantially Equivalent on August 11, 1976, 9 days after the submission was received.
What is the product code of K760352?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.