Medical Device Manufacturer · US , Cleveland , TN

Prima, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1994
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Prima, Inc. Anesthesiology
18 devices
1-18 of 18
Cleared May 22, 1995
PRIMA VENTILATOR HOSES
K952010 · BZO
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA BREATHING BAGS
K952011 · BZO
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA CUSTOM ANESTESIA CIRCUIT
K952012 · BZO
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA GUEDEL AIRWAYS
K952013 · BTR
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K952014 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K952016 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA MAPLESON D CIRCUIT
K952017 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA COAXIAL CIRCUITS
K952018 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA ADULT GAS SAMPLING CIRCUITS
K952019 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · CAI
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA HYUPERINFLATION SYSTEM
K952021 · BZR
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA VOLUMN VENTILATORSS
K952022 · BZO
Anesthesiology · 24d
Cleared May 19, 1995
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K952009 · CAI
Anesthesiology · 21d
Cleared Dec 02, 1994
PRIMA, INC. CORRUGATED TUBING
K944531 · BZO
Anesthesiology · 78d
Cleared Dec 02, 1994
PRIMA, INC. VENTILATOR HOSES
K944532 · BZA
Anesthesiology · 78d
Cleared Nov 29, 1994
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
K944533 · CAI
Anesthesiology · 75d
Cleared Nov 29, 1994
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K944534 · BZA
Anesthesiology · 75d
Cleared Nov 29, 1994
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K944535 · BZA
Anesthesiology · 75d
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