HANS RUDOLPH NASAL CPAP MASK— 510(k) K962848
Substantially EquivalentHans Rudolph, Inc.
FDA 510(k) clearance K962848 for HANS RUDOLPH NASAL CPAP MASK, Substantially Equivalent on 1996-10-16. Applicant: Hans Rudolph, Inc.. Device class: 1.
Clearance details
- Applicant
- Hans Rudolph, Inc.
- Product code
- Code BYG
- Device class
- Class 1
- Regulation
- 21 CFR 868.5580
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, MO, US
Recent devices under product code BYG
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- K020759 — 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
- K960401 — ULTIMATE SEAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.