Disposable Condensate Bottle for 7200 Ventilator
FDA 510(k) K873447 · Dhd Medical Products Div. Diemolding Corp.
510(k) numberK873447
Submission
- Device name
- Disposable Condensate Bottle for 7200 Ventilator
- Applicant
- Dhd Medical Products Div. Diemolding Corp.
Canastota, NY, US - Received
- August 17, 1987
- Decision date
- October 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYH – Drain, Tee (Water Trap)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5995
- Specialty
- Anesthesiology
Other 510(k)s with product code BYH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946057 | Aqualarm Moisture Sensor Model P85000BYH · Traditional | Pegasus Research Corp. | 05/05/1995SE |
| K932722 | Carie Med-Tech Model 210 Rainout Drainage SystemBYH · Traditional | Carie Med-Tech Services, Inc. | 08/06/1993SE |
| K921624 | Disposable Volume Vent/Anesthesia Breath CircuitsBYH · Traditional | Intertech Resources, Inc. | 06/30/1992SE |
| K900047 | Thayer Suction Evacuation Condensate CollectionBYH · Traditional | Thayer Medical Corp. | 04/23/1990SE |
| K897057 | Thayer Semi-Rigid Condensate Collection SystemBYH · Traditional | Thayer Medical Corp. | 03/16/1990SE |
| K900591 | Vent-Trap Cat# WR1000BYH · Traditional | Ventlab Corp. | 03/09/1990SE |
| K895479 | Thayer Semi-Rigid Condensate Collection SystemBYH · Traditional | Thayer Medical Corp. | 03/09/1990SE |
| K885088 | Thayer Flexible Condensate Collection SystemBYH · Traditional | Thayer Medical Corp. | 01/12/1989SE |
| K882739 | Intertech Large Volume Water Trap (LVW)BYH · Traditional | Intertech Resources, Inc. | 08/09/1988SE |
| K881790 | Safety DrainBYH · Traditional | Ballard Medical Products | 06/21/1988SE |
More from Ballard Medical Products
| 510(k) | Device | Decision |
|---|---|---|
| K883988 | Non-Rebreathing Tee Piece (NRTP)CBP · Traditional | 10/07/1988SE |
| K881935 | Microcirrus Medical NebulizerCAF · Traditional | 06/22/1988SE |
| K881178 | CuffcheckBSK · Traditional | 04/14/1988SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | 03/09/1988SE |
| K874047 | AsthmakitCAF · Traditional | 02/29/1988SE |
| K860885 | Straight Connectors, 15MM, 30MM & 19MMBZA · Traditional | 03/20/1986SE |
| K860882 | Disposable CatheterBZA · Traditional | 03/20/1986SE |
| K860880 | Ventilator Circuits (Various Types)BZO · Traditional | 03/20/1986SE |
| K860879 | Disposable Ventilator CircuitsBZO · Traditional | 03/20/1986SE |
| K860878 | British Breathing Circuit SystemBZA · Traditional | 03/20/1986SE |
Questions and answers
When was Disposable Condensate Bottle for 7200 Ventilator cleared by the FDA?
Disposable Condensate Bottle for 7200 Ventilator (K873447) received a 510(k) decision of Substantially Equivalent on October 30, 1987, 74 days after the submission was received.
What is the product code of K873447?
The FDA product code is BYH – Drain, Tee (Water Trap), a Class I (low risk) device regulated under 21 CFR 868.5995.