FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL CUFF PV GAUGE
K Number: K900755
·
Decision Apr 26, 1990
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
9
Review Days
69
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Basic Information
- Device Name
- DIGITAL CUFF PV GAUGE
- K Number
- K900755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- International Medical Products, Inc.
- Date Received
- February 16, 1990
- Decision Date
- April 26, 1990
- Product Code
- BSK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
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Cuffix
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| K Number | Device Name | ||
|---|---|---|---|
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| K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE | Oct 30, 1997 | Substantially Equivalent |
| K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS | Jun 16, 1997 | Substantially Equivalent |
| K920077 | NIKKISO NK PUMP | Sep 29, 1993 | Substantially Equivalent |
| K923942 | RHOMBO MEDICAL RHOMBO-FILL | Mar 24, 1993 | Substantially Equivalent |
| K864984 | ROBINJECT | Jun 29, 1987 | Substantially Equivalent |
| K863609 | SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 | Feb 25, 1987 | Substantially Equivalent |
| K861539 | NIKKISO INFUSION PUMP MODEL PFA-02 | Jul 31, 1986 | Substantially Equivalent |