4200 PNEUMATIC MOUTH SHUTTER— 510(k) K791705
Substantially EquivalentHans Rudolph, Inc.
FDA 510(k) clearance K791705 for 4200 PNEUMATIC MOUTH SHUTTER, Substantially Equivalent on 1979-10-04. Applicant: Hans Rudolph, Inc.. Device class: 2.
Clearance details
- Applicant
- Hans Rudolph, Inc.
- Product code
- Code CCM
- Device class
- Class 2
- Regulation
- 21 CFR 868.1750
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CCM
view allMore clearances from Hans Rudolph, Inc.
view all- K071149 — HRI 6500, 6600 AND 6700 SERIES V2MASKS
- K030822 — 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
- K030515 — HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
- K020759 — 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
- K962848 — HANS RUDOLPH NASAL CPAP MASK
Data sourced from openFDA. This site is unofficial and independent of the FDA.