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 | Device Class | Medical Specialty |
|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXC), ordered by most recent decision date.
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
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MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
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Compremium Compartment Compressibility Monitoring System (CPM#1)
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Ace Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K972183 | DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL | Aug 26, 1997 | Substantially Equivalent |
| K955472 | ACE HUMERUS & RADIUS PLATES | Apr 1, 1996 | Substantially Equivalent |
| K955388 | ACE-DUPONT COMPOSITE RINGS | Jan 31, 1996 | Substantially Equivalent |
| K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW | Oct 31, 1995 | Substantially Equivalent |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Oct 12, 1995 | Substantially Equivalent |
| K950618 | ACE SUPRACONDYLAR PLATE | May 10, 1995 | Substantially Equivalent |
| K933968 | ACE PELVIC STABILIZER | Jun 16, 1994 | Substantially Equivalent |
| K931652 | ACE 6.5 MM BONE SCREW | Apr 28, 1994 | Substantially Equivalent for Some Indications |
| K930592 | ACE UNIVERSAL RECONSTRUCTION PLATE | Jul 26, 1993 | Substantially Equivalent |
| K912598 | ACE CORTICAL BONE SCREW | Nov 27, 1991 | Substantially Equivalent for Some Indications |