FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

ACE INTRA COMPARTMENTAL PRESSURE MONITOR

K Number: K873684 · Decision Jan 20, 1988
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
21
Review Days
128

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Basic Information

Device Name
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K Number
K873684
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Ace Medical Co.
Date Received
September 14, 1987
Decision Date
January 20, 1988
Product Code
LXC
Advisory Committee
Unknown
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LXC Monitor, Pressure, Intracompartmental

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Other Clearances by Ace Medical Co.

K Number Device Name
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K955388 ACE-DUPONT COMPOSITE RINGS
K954485 6.5MM SOLID CANCELLOUS BONE SCREW
K954069 ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K950618 ACE SUPRACONDYLAR PLATE
K933968 ACE PELVIC STABILIZER
K931652 ACE 6.5 MM BONE SCREW
K930592 ACE UNIVERSAL RECONSTRUCTION PLATE
K912598 ACE CORTICAL BONE SCREW
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