7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS— 510(k) K030822
Substantially EquivalentHans Rudolph, Inc.
FDA 510(k) clearance K030822 for 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS, Substantially Equivalent on 2003-06-03. Applicant: Hans Rudolph, Inc.. Device class: 2.
Clearance details
- Applicant
- Hans Rudolph, Inc.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Recent devices under product code BZD
view allMore clearances from Hans Rudolph, Inc.
view all- K071149 — HRI 6500, 6600 AND 6700 SERIES V2MASKS
- 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
- K960401 — ULTIMATE SEAL
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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.