Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973347
Device Classification Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
More FDA Info for this Device
510(K) Number
K973347
Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant
SPIRACLE TECHNOLOGY
16520 HARBOR BLVD., UNIT D
FOUNTAIN VALLEY, CA 92708 US
Other 510(k) Applications for this Company
Contact
GUY GANSEL
Other 510(k) Applications for this Contact
Regulation Number
868.2600
More FDA Info for this Regulation Number
Classification Product Code
CAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/1997
Decision Date
07/23/1998
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