EMS Nasal CPAP Mask
FDA 510(k) K972605 · Engineered Medical Systems
510(k) numberK972605
Submission
- Device name
- EMS Nasal CPAP Mask
- Applicant
- Engineered Medical Systems
Indianapolis, IN, US - Received
- July 11, 1997
- Decision date
- January 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code BZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253553 | OrionBZD · Traditional | Resmed Corp | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…BZD · Traditional | Dcstar, Inc. | 05/21/2026SE |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | BMC Medical Co., Ltd. | 04/29/2026SE |
| K252338 | MySleepDashBZD · Traditional | Somnetics International, Inc. (Dba Transcend Inc) | 04/17/2026SE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
More from Resmed Corp
| 510(k) | Device | Decision |
|---|---|---|
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K062104 | Talking TrachBTO · Traditional | 04/20/2007SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | 04/19/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | 03/14/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
Questions and answers
When was EMS Nasal CPAP Mask cleared by the FDA?
EMS Nasal CPAP Mask (K972605) received a 510(k) decision of Substantially Equivalent on January 28, 1998, 201 days after the submission was received.
What is the product code of K972605?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.