Aqualarm Moisture Sensor Model P85000
FDA 510(k) K946057 · Pegasus Research Corp.
510(k) numberK946057
Submission
- Device name
- Aqualarm Moisture Sensor Model P85000
- Applicant
- Pegasus Research Corp.
Costa Mesa, CA, US - Received
- December 12, 1994
- Decision date
- May 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K873447 | Disposable Condensate Bottle for 7200 VentilatorBYH · Traditional | Dhd Medical Products Div. Diemolding Corp. | 10/30/1987SE |
More from Dhd Medical Products Div. Diemolding Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K122857 | Hope Continuous Nebulizer Model HOPE-11310, Heart Nebulizer Model HEART-100609…CAF · Traditional | 11/07/2012SE |
| K020700 | PMH 5000 Heated Humidifier for Respiratory TherapyBTT · Traditional | 04/26/2004SE |
| K013856 | PMH 1000 Heated HumidifierBTT · Traditional | 02/21/2003SE |
| K983783 | Heated HumidifierBTT · Traditional | 10/24/2000SE |
| K962534 | Thera-Mist Nebulizer MODEL-P3000CAF · Traditional | 02/28/1997SE |
| K915890 | Autoclavable Thera-Mist Humidifier P3600, ModifiedBTT · Traditional | 06/24/1992SE |
| K914465 | Autoclavable Version Thera-Mist Nebulizer, P32000CAF · Traditional | 03/31/1992SE |
| K903489 | Thera-Mist TM Volumina Incent Spirometer, P40000BWF · Traditional | 12/10/1990SE |
| K894000 | Thera-Mist HumidifierBTT · Traditional | 08/28/1989SE |
| K893942 | Thera-Mist(Tm) Nebulizer, Model 30000CAF · Traditional | 08/28/1989SE |
Questions and answers
When was Aqualarm Moisture Sensor Model P85000 cleared by the FDA?
Aqualarm Moisture Sensor Model P85000 (K946057) received a 510(k) decision of Substantially Equivalent on May 5, 1995, 144 days after the submission was received.
What is the product code of K946057?
The FDA product code is BYH – Drain, Tee (Water Trap), a Class I (low risk) device regulated under 21 CFR 868.5995.