Temp-Check Adaptor, Y-Configuration
FDA 510(k) K830921 · Cygnus Research Corp.
510(k) numberK830921
Submission
- Device name
- Temp-Check Adaptor, Y-Configuration
- Applicant
- Cygnus Research Corp.
Mchenry, IL, US - Received
- March 22, 1983
- Decision date
- May 2, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | Unicor, Inc. | 09/18/1995SE |
| K952022 | Prima Volumn VentilatorssBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952011 | Prima Breathing BagsBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952010 | Prima Ventilator HosesBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K945740 | Infant Flow SystemBZO · Traditional | Hamilton Medical, Inc. | 03/23/1995SE |
| K944531 | Prima, Inc. Corrugated TubingBZO · Traditional | Prima, Inc. | 12/02/1994SE |
| K942572 | Volume VentilatorBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
More from Med-Plastics Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K831556 | Vapor-Phase Humidifier SystemBTT · Traditional | 07/19/1983SE |
| K831163 | Lo-Comp RESERVOIR-RE-1000BTT · Traditional | 05/03/1983SE |
| K830923 | Temp-Check Adaptor, Straight ConfiguraBZO · Traditional | 05/03/1983SE |
| K830922 | Temp-Check Adaptor, Tee-ConfigurationBZO · Traditional | 05/02/1983SE |
Questions and answers
When was Temp-Check Adaptor, Y-Configuration cleared by the FDA?
Temp-Check Adaptor, Y-Configuration (K830921) received a 510(k) decision of Substantially Equivalent on May 2, 1983, 41 days after the submission was received.
What is the product code of K830921?
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.