FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPRESSAR DISPOSABLE DISC
K Number: K831337
·
Decision Jul 19, 1983
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
32
Review Days
85
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Basic Information
- Device Name
- COMPRESSAR DISPOSABLE DISC
- K Number
- K831337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instromedix, Inc.
- Date Received
- April 25, 1983
- Decision Date
- July 19, 1983
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Instromedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | Jul 23, 1997 | Substantially Equivalent |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | Jul 18, 1997 | Substantially Equivalent |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | Apr 8, 1996 | Substantially Equivalent |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | Jan 16, 1996 | Substantially Equivalent |
| K945476 | HEARTHWATCH III(TM) | Nov 9, 1995 | Substantially Equivalent |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | Oct 31, 1995 | Substantially Equivalent |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | Sep 7, 1995 | Substantially Equivalent |
| K943931 | CARRYALL ENHANCEMENTS | Apr 4, 1995 | Substantially Equivalent |
| K935586 | PRINCE | Nov 8, 1994 | Substantially Equivalent |
| K925639 | CARDIOMAGIC SOFTWARE | Jun 22, 1993 | Substantially Equivalent |