NOVAMETRIX CPAP NASAL CANNULA
FDA 510(k) clearance K792722 · decided 1980-01-24
Clearance details
- K-number
- K792722
- Device name
- NOVAMETRIX CPAP NASAL CANNULA
- Applicant
- Novametrix Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-31
- Decision date
- 1980-01-24
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
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| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| SleepRes PAP System (K251770) | Sleepres, Inc. | 2025-12-15 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TCO2M MODEL 818 MONITOR (P810022/S014) | Novametrix Medical Systems, Inc. | 1987-10-09 |
| TCO2M MODEL 818 MONITOR (P810022/S013) | Novametrix Medical Systems, Inc. | 1987-01-29 |
| TCO2M MODEL 818 MONITOR (P810022/S012) | Novametrix Medical Systems, Inc. | 1986-06-05 |
| TCO2M MODEL 818 MONITOR (P810022/S011) | Novametrix Medical Systems, Inc. | 1985-11-21 |
| TCO2M MODEL 818 MONITOR (P810022/S009) | Novametrix Medical Systems, Inc. | 1985-09-03 |
| TCO2M MODEL 818 MONITOR (P810022/S010) | Novametrix Medical Systems, Inc. | 1985-07-01 |
| TCO2M MODEL 818 MONITOR (P810022/S008) | Novametrix Medical Systems, Inc. | 1985-03-11 |
| TCO2M MODEL 818 MONITOR (P810022/S007) | Novametrix Medical Systems, Inc. | 1984-12-04 |