FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANS RUDOLPH NASAL CPAP MASK
K Number: K962848
·
Decision Oct 16, 1996
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
11
Review Days
86
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Basic Information
- Device Name
- HANS RUDOLPH NASAL CPAP MASK
- K Number
- K962848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hans Rudolph, Inc.
- Date Received
- July 22, 1996
- Decision Date
- October 16, 1996
- Product Code
- BYG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
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Other Clearances by Hans Rudolph, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071149 | HRI 6500, 6600 AND 6700 SERIES V2MASKS | Feb 1, 2008 | Substantially Equivalent |
| K030822 | 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS | Jun 3, 2003 | Substantially Equivalent |
| K030515 | HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS | May 2, 2003 | Substantially Equivalent |
| K020759 | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT | Aug 13, 2002 | Substantially Equivalent |
| K960401 | ULTIMATE SEAL | Jun 20, 1996 | Substantially Equivalent |
| K946077 | DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS | Sep 15, 1995 | Substantially Equivalent |
| K945894 | MASK, GAS, ANESTHETIC | Jan 27, 1995 | Substantially Equivalent |
| K933583 | NONREBREATHING VALVE | Jan 3, 1994 | Substantially Equivalent |
| K932147 | NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE | Aug 20, 1993 | Substantially Equivalent |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | Oct 4, 1979 | Substantially Equivalent |