NHJ — Device, Positive Pressure Breathing, Intermittent Class II
FDA Device Classification
Classification Details
- Product Code
- NHJ
- Device Class
- Class II
- Regulation Number
- 868.5905
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K242438 | breas medical | Clearo | May 16, 2025 |
| K231728 | abmrc | BiWaze Clear System | April 8, 2024 |
| K213564 | abmrc | BiWaze Clear System | December 21, 2022 |
| K200988 | hill-rom services pte | Maximus System | May 26, 2020 |
| K191912 | abmrc | BiWaze Cough | March 27, 2020 |
| K192143 | hill-rom services pte | Maximus System | February 14, 2020 |
| K151689 | hill-rom services pte | MetaNeb 4 System | March 17, 2016 |
| K140598 | dima italia | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | October 16, 2014 |
| K140605 | dima italia | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | October 3, 2014 |
| K132988 | lung assist | VITAL COUGH | March 28, 2014 |
| K124032 | hill-rom services pte | METANEB | April 25, 2013 |
| K113549 | seoil pacific | COMFORT COUGH | February 21, 2013 |
| K121955 | respironics | COUGHASSIST T70 DEVICE | December 14, 2012 |
| K120277 | lung assist | VITAL COUGH | September 12, 2012 |
| K072292 | dima italia | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS | January 7, 2008 |
| K051964 | comedica | POWERNEB | December 1, 2005 |
| K003684 | vortran medical technology 1 | PERCUSSIVENEB, MODEL PN-2001 | February 23, 2001 |
| K002598 | j. h. emerson | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL | November 22, 2000 |
| K982016 | vortran medical technology 1 | PIPER IPPB MODEL 2055 | November 3, 1998 |
| K981726 | vortran medical technology 1 | PERCUSSIVETECH HF, MODEL 2001 | September 17, 1998 |