FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE
K Number: K932147
·
Decision Aug 20, 1993
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
11
Review Days
108
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE
- K Number
- K932147
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hans Rudolph, Inc.
- Date Received
- May 4, 1993
- Decision Date
- August 20, 1993
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSJ), ordered by most recent decision date.
SuperNO2VA Device
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE ADHESIVE FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
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 |
| K962848 | HANS RUDOLPH NASAL CPAP MASK | Oct 16, 1996 | 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 |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | Oct 4, 1979 | Substantially Equivalent |