Hans Rudolph Nasal CPAP Mask
FDA 510(k) K962848 · Hans Rudolph, Inc.
510(k) numberK962848
Submission
- Device name
- Hans Rudolph Nasal CPAP Mask
- Applicant
- Hans Rudolph, Inc.
Kansas City, MO, US - Received
- July 22, 1996
- Decision date
- October 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BYG – Mask, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5580
- Specialty
- Anesthesiology
Other 510(k)s with product code BYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963298 | First Aid Kit(S)BYG · Traditional | Vector, Inc. | 11/06/1996SE |
| K945482 | Disposable, CPAP Oxygen MaskBYG · Traditional | Fvtnks | 09/19/1995SE |
| K953464 | Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional | Westmed, Inc. | 09/18/1995SE |
| K953039 | Various Adult & Child High Con/Nonrebreath Oxy MasksBYG · Traditional | Dadsun Corp., Ltd. | 09/15/1995SE |
| K945472 | Westmed Pediatric and Adult Aerosol MaskBYG · Traditional | Westmed Intl. | 02/07/1995SE |
| K942907 | Jemsdal MaskBYG · Traditional | Respan Products, Inc. | 08/31/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K940887 | System 22 Adult MaskBYG · Traditional | Medic-Aid , Ltd. | 04/19/1994SE |
| K931952 | Medway Oxygen MaskBYG · Traditional | Medway | 08/20/1993SE |
| K924069 | Surgico Oxygen MaskBYG · Traditional | Gujarat Surgico, Ltd. | 02/04/1993SE |
More from Gujarat Surgico, Ltd.
| 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 |
| K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640…BZD · Traditional | 08/13/2002SE |
| 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 Hans Rudolph Nasal CPAP Mask cleared by the FDA?
Hans Rudolph Nasal CPAP Mask (K962848) received a 510(k) decision of Substantially Equivalent on October 16, 1996, 86 days after the submission was received.
What is the product code of K962848?
The FDA product code is BYG – Mask, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5580.