Atlas FDA

ATRION MEDICAL QL INFLATION DEVICE

FDA 510(k) clearance K032840 · decided 2004-03-03

Clearance details

K-number
K032840
Device name
ATRION MEDICAL QL INFLATION DEVICE
Applicant
Atrion Medical Products, Inc.
Decision
Substantially Equivalent
Date received
2003-09-11
Decision date
2004-03-03
Days to decision
174 days
Clearance type
Traditional
Product code
KOE
Device class
2
Regulation number
876.5520
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Arab, AL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KESTREL NO. 695 HEATER (P820087/S011)Atrion Medical Products, Inc.1988-06-17
KESTREL NO. 695 HEATER (P820087/S009)Atrion Medical Products, Inc.1988-01-19
KESTREL NO. 695 HEATER (P820087/S008)Atrion Medical Products, Inc.1987-11-27
KESTREL NO. 695 HEATER (P820087/S010)Atrion Medical Products, Inc.1987-10-30
KESTREL NO. 695 HEATER (P820087/S007)Atrion Medical Products, Inc.1987-09-09
KESTREL NO. 695 HEATER (P820087/S006)Atrion Medical Products, Inc.1986-07-07
KESTREL NO. 695 HEATER (P820087/S005)Atrion Medical Products, Inc.1986-07-07
KESTREL NO. 695 HEATER (P820087/S004)Atrion Medical Products, Inc.1985-11-18