510(k) K973004
- Device
- KNIGHTSTAR 335
- Applicant
- PURITAN BENNETT CORP.
- 510(k) number
- K973004
- Product code
- MNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-07-16
- Date received
- 1997-08-13
- Regulation
- 868.5895
- Classification name
- Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- C. MARSHALL SMITH
- Address
- 9728 Pflumm Rd. P.O.Box 15915 Lenexa KS US 66215 66215
FDA Registration Numbers#
- 3004604967
- 3007603826
- 3033526676
- 3009156722
- 8010042
- 3023272766
- 3006783791
- 3008264065
- 3011120183
- 3001400310
- 3004428458
- 3010817335
- 3013154126
- 3029227324
- 2518422
- 3013190994
- 2085602
- 3002797442
- 3038562397
- 3007573469
- 3014631252
- 9611451
- 9617566
- 3020283264
- 3018783526
- 3000126629
Source Documents#
Other 510(k) Records For Product Code MNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 |
| K242931 | HFT750U | Mekics Co., Ltd. | 2025-05-15 |
| K240779 | Vivo 3 | Breas Medical AB | 2024-12-13 |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023-07-06 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022-07-01 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare Limited | 2020-03-09 |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | Fisher and Paykel Healthcare Limited | 2017-08-24 |
| K122715 | STELLAR 150 | Resmed Germany, Inc. | 2013-06-17 |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-12-14 |
| K113640 | STELLAR 150 | Resmed Germany, Inc. | 2012-04-05 |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | 2011-04-05 |
| K103167 | STELLAR 150 | Resmed Germany, Inc. | 2011-03-01 |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | 2009-01-09 |
Legacy Summary#
summary
FDA Review#
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