Thayer Semi-Rigid Condensate Collection System
FDA 510(k) K895479 · Thayer Medical Corp.
510(k) numberK895479
Submission
- Device name
- Thayer Semi-Rigid Condensate Collection System
- Applicant
- Thayer Medical Corp.
Tucson, AZ, US - Received
- September 11, 1989
- Decision date
- March 9, 1990
- 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 |
| 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 |
| K873447 | Disposable Condensate Bottle for 7200 VentilatorBYH · Traditional | Dhd Medical Products Div. Diemolding Corp. | 10/30/1987SE |
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| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberNVP · Traditional | 05/19/2017SE |
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| K993101 | LiteaireCAF · Traditional | 10/26/2000SE |
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Questions and answers
When was Thayer Semi-Rigid Condensate Collection System cleared by the FDA?
Thayer Semi-Rigid Condensate Collection System (K895479) received a 510(k) decision of Substantially Equivalent on March 9, 1990, 179 days after the submission was received.
What is the product code of K895479?
The FDA product code is BYH – Drain, Tee (Water Trap), a Class I (low risk) device regulated under 21 CFR 868.5995.