BYD — Condenser, Heat And Moisture (Artificial Nose) Class I
FDA product code BYD covers "Condenser, Heat And Moisture (Artificial Nose)", a Class I medical device regulated under 21 CFR 868.5375. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYD
- Device Class
- Class I
- Regulation Number
- 868.5375
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K955008 | intertech resources | HEAT & MOISTURE EXCHANGER | January 30, 1996 |
| K954194 | engstrom medical | DISPOSABLE HME/FILTER | October 20, 1995 |
| K953580 | intertech resources | HEAT MOISTURE EXCHANGER | September 15, 1995 |
| K953507 | icor | TYPE 1 & 2 (HUMIDAIR I & II) | September 7, 1995 |
| K953540 | edentec | EEE | August 25, 1995 |
| K953491 | gibeck | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | August 25, 1995 |
| K953620 | hospitak | WARM N WET HMEF W/LUER ADAPTER | August 25, 1995 |
| K953619 | hospitak | WARM N WET HME W/LUER ADAPTER | August 25, 1995 |
| K953544 | gibeck | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | August 25, 1995 |
| K952845 | gibeck | HUMID-VENT TRACH-VENT | July 25, 1995 |
| K952844 | gibeck | HUMID-VENT 2 | July 20, 1995 |
| K952750 | gibeck | HUMID-VENT 1 | July 20, 1995 |
| K952823 | icor | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXR | July 13, 1995 |
| K952084 | gibeck | HUMID-VENT FILTER PEDI | June 12, 1995 |
| K952036 | mallinckrodt medical | FLEXLIFE | June 8, 1995 |
| K946209 | med-plastics intl | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | June 8, 1995 |
| K951856 | gibeck | HUMID-VENT MICRO | June 7, 1995 |
| K950447 | vital signs | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | February 21, 1995 |
| K945359 | artema medical | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | February 21, 1995 |
| K945657 | tec ii medical | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | December 7, 1994 |