HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS— 510(k) K030515
Substantially EquivalentHans Rudolph, Inc.
FDA 510(k) clearance K030515 for HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS, Substantially Equivalent on 2003-05-02. Applicant: Hans Rudolph, Inc.. Device class: 2.
Clearance details
- Applicant
- Hans Rudolph, Inc.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Recent devices under product code CBK
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
- 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
- K960401 — ULTIMATE SEAL
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.