FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
K Number: K912446
·
Decision Dec 12, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
134
Applicant Total
6
Review Days
192
Basic Information
- Device Name
- MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
- K Number
- K912446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VASAMEDICS, L.L.C.
- Date Received
- June 3, 1991
- Decision Date
- December 12, 1991
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
Elfor-L
FDA 510(k)
FDA Class 2
·Cardiovascular
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
FloPatch FP120
FDA 510(k)
FDA Class 2
·Cardiovascular
GEM FLOW COUPLER Monitor (GEM1020M-2)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by VASAMEDICS, L.L.C.
| K Number | Device Name | ||
|---|---|---|---|
| K962700 | VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT | Apr 9, 1997 | Substantially Equivalent |
| K961368 | TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT | Oct 11, 1996 | Unknown |
| K951832 | LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 | Mar 21, 1996 | Substantially Equivalent |
| K951486 | MODEL PV2000 VASCULAR MICROLABORATORY | Jun 29, 1995 | Substantially Equivalent |
| K911763 | LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) | Aug 13, 1991 | Substantially Equivalent |