The following data is part of a premarket notification filed by Hans Rudolph, Inc. with the FDA for Hans Rudolph Nasal Cpap Mask.
Device ID | K962848 |
510k Number | K962848 |
Device Name: | HANS RUDOLPH NASAL CPAP MASK |
Classification | Mask, Oxygen |
Applicant | HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
Contact | Kevin Rudolph |
Correspondent | Kevin Rudolph HANS RUDOLPH, INC. 7200 WYANDOTTE Kansas City, MO 64114 |
Product Code | BYG |
CFR Regulation Number | 868.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-22 |
Decision Date | 1996-10-16 |