Raincoat
FDA 510(k) K863910 · Artec Environmental Monitoring Division
510(k) numberK863910
Submission
- Device name
- Raincoat
- Applicant
- Artec Environmental Monitoring Division
Noblesville, IN, US - Received
- October 8, 1986
- Decision date
- October 20, 1986
- 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 |
|---|---|---|
| K900839 | The Carolina RockerKNN · Traditional | 04/18/1990SE |
| K896886 | Artec Respond Pulmonary ResuscitatorBTM · Traditional | 02/06/1990SE |
| K873043 | Mouth to Face ResuscitatorBTM · Traditional | 09/28/1987SE |
| K854573 | Anesthesia Shutoff Valve Positive ClosureCAI · Traditional | 01/03/1986SE |
| K832512 | Airway MasksCAE · Traditional | 01/17/1984SE |
| K830056 | Artec Twist ValveBTC · Traditional | 03/09/1983SE |
Questions and answers
When was Raincoat cleared by the FDA?
Raincoat (K863910) received a 510(k) decision of Substantially Equivalent on October 20, 1986, 12 days after the submission was received.
What is the product code of K863910?
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.