Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K974848
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
510(K) Number
K974848
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
HOUGEN MFG., INC.
3001 HOUGEN DR.
SWARTZ CREEK, MI 48473 US
Other 510(k) Applications for this Company
Contact
JEFFERY R MILLER
Other 510(k) Applications for this Contact
Regulation Number
868.5690
More FDA Info for this Regulation Number
Classification Product Code
BWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/1997
Decision Date
08/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact