BYD · Condenser, Heat And Moisture (Artificial Nose)
Anesthesiology · 21 CFR 868.5375 · Class 1
Overview
| Product Code | BYD |
|---|---|
| Device Name | Condenser, Heat And Moisture (Artificial Nose) |
| Regulation | 21 CFR 868.5375 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | Jan 30, 1996 | SESE |
| K954194 | DISPOSABLE HME/FILTER | Engstrom Medical | Oct 20, 1995 | SESE |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | Sep 15, 1995 | SESE |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | Sep 7, 1995 | SESE |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | Aug 25, 1995 | SESE |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | Aug 25, 1995 | SESE |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | Aug 25, 1995 | SESE |
| K953540 | EEE | Edentec Corp. | Aug 25, 1995 | SESE |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | Aug 25, 1995 | SESE |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | Jul 25, 1995 | SESE |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | Jul 20, 1995 | SESE |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | Jul 20, 1995 | SESE |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | Jul 13, 1995 | SESE |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | Jun 12, 1995 | SESE |
| K952036 | FLEXLIFE | Mallinckrodt Medical | Jun 8, 1995 | SESE |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | Jun 8, 1995 | SESE |
| K951856 | HUMID-VENT MICRO | Gibeck, Inc. | Jun 7, 1995 | SESE |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | Feb 21, 1995 | SESE |
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | Feb 21, 1995 | SESE |
| K945657 | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | Tec II Medical, Inc. | Dec 7, 1994 | SESE |
Top Applicants
- Icor AB — 9 clearances
- Gibeck, Inc. — 7 clearances
- Gibeck Respiration — 6 clearances
- Artema Medical AB — 5 clearances
- Mallinckrodt Medical — 5 clearances
