Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
510(k) Number |
K895115 |
Device Name |
FRANK INHALER THERMAL S |
Applicant |
BUTTNER-FRANK GMBH |
8520 ERLANGEN-TENNENLOHE |
AM WOLFSMANTEL 9/GEWERBEGABIET |
POSTFACH 1266,
DE
|
|
Applicant Contact |
BLANK |
Correspondent |
BUTTNER-FRANK GMBH |
8520 ERLANGEN-TENNENLOHE |
AM WOLFSMANTEL 9/GEWERBEGABIET |
POSTFACH 1266,
DE
|
|
Correspondent Contact |
BLANK |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 08/15/1989 |
Decision Date | 05/18/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|