The following data is part of a premarket notification filed by Noble Marketing with the FDA for Rxpeakflow.
Device ID | K101380 |
510k Number | K101380 |
Device Name: | RXPEAKFLOW |
Classification | Meter, Peak Flow, Spirometry |
Applicant | NOBLE MARKETING 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
Contact | Laura Lyons |
Correspondent | Laura Lyons NOBLE MARKETING 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
Product Code | BZH |
CFR Regulation Number | 868.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-17 |
Decision Date | 2010-09-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00311917047201 | K101380 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RXPEAKFLOW 77408190 3677328 Dead/Cancelled |
Noble Logos 2008-02-28 |