MNT — Sv70 Ventilator Class II
FDA product code MNT covers "Sv70 Ventilator", a Class II medical device regulated under 21 CFR 868.5895. 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
- MNT
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252182 | shenzhen mindray bio-medical electronics co | SV70 Ventilator (SV70) | April 6, 2026 |
| K242931 | mekics co | HFT750U | May 15, 2025 |
| K240779 | breas medical | Vivo 3 | December 13, 2024 |
| K233643 | fisher and paykel healthcare | F&P Airvo 3 NIV (PT311US) | August 9, 2024 |
| K230173 | maquet critical care | Servo-air Lite Ventilator System | July 6, 2023 |
| K213521 | nihon kohden orangemed | Nihon Kohden NKV-330 Ventilator System | July 1, 2022 |
| K191624 | fisher and paykel healthcare limited | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Versio | March 9, 2020 |
| K170367 | fisher and paykel healthcare limited | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large | August 24, 2017 |
| K122715 | resmed germany | STELLAR 150 | June 17, 2013 |
| K121623 | respironics | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | December 14, 2012 |
| K113640 | resmed germany | STELLAR 150 | April 5, 2012 |
| K102985 | respironics | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | April 5, 2011 |
| K103167 | resmed germany | STELLAR 150 | March 1, 2011 |
| K090113 | breas medical | BREAS VIVO 40 SYSTEM | May 14, 2009 |
| K082660 | respironics california | V60 VENTILATOR, MODEL V8000 | January 9, 2009 |
| K071702 | breas medical | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | February 15, 2008 |
| K060044 | fisher and paykel healthcare | ACUTE CARE FACE MASK, MODEL RT040 | April 6, 2006 |
| K053607 | breas medical | BREAS VIVO 40 SYSTEM | March 16, 2006 |
| K003075 | mallinckrodt | KNIGHTSTAR 330 VENTILATOR | December 11, 2001 |
| K990574 | respironics | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 | May 24, 1999 |