7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit
FDA 510(k) K020759 · Hans Rudolph, Inc.
510(k) numberK020759
Submission
- Device name
- 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit
- Applicant
- Hans Rudolph, Inc.
Kansas City, MO, US - Received
- March 7, 2002
- Decision date
- August 13, 2002
- 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
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| 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 |
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| 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 |
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More from Resmed Corp
| 510(k) | Device | Decision |
|---|---|---|
| K071149 | Hri 6500, 6600 and 6700 Series V2MASKSBZD · Traditional | 02/01/2008SE |
| K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/Nppv MasksBZD · Traditional | 06/03/2003SE |
| K030515 | Hans Rudolph 7500 Series Reusable Oro-Nasal Niv MasksCBK · Traditional | 05/02/2003SE |
| K962848 | Hans Rudolph Nasal CPAP MaskBYG · Traditional | 10/16/1996SE |
| K960401 | Ultimate SealKGB · Traditional | 06/20/1996SE |
| K946077 | Directional Control Valves Inflatable Balloon-Type and ControllersBZC · Traditional | 09/15/1995SE |
| K945894 | Mask, Gas, AnestheticBSJ · Traditional | 01/27/1995SE |
| K933583 | Nonrebreathing ValveKGB · Traditional | 01/03/1994SE |
| K932147 | Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional | 08/20/1993SE |
| K791705 | 4200 Pneumatic Mouth ShutterCCM · Traditional | 10/04/1979SE |
Questions and answers
When was 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit cleared by the FDA?
7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit (K020759) received a 510(k) decision of Substantially Equivalent on August 13, 2002, 159 days after the submission was received.
What is the product code of K020759?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.