FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DATA TRAC ANESTHESIOLOGY RECORDER
K Number: K851904
·
Decision May 10, 1985
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
136
Review Days
10
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DATA TRAC ANESTHESIOLOGY RECORDER
- K Number
- K851904
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Datascope Corp.
- Date Received
- April 30, 1985
- Decision Date
- May 10, 1985
- Product Code
- KZD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZD), ordered by most recent decision date.
INFUSION DYNAMICS POWER INFUSER
FDA 510(k)
FDA Class 1
·General Hospital
MSI PRESSURE INFUSOR
FDA 510(k)
FDA Class 1
·General Hospital
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
FDA 510(k)
FDA Class 1
·General Hospital
PRESSURIZER
FDA 510(k)
FDA Class 1
·General Hospital
PRESSURE INFUSION CUFF
FDA 510(k)
FDA Class 1
·General Hospital
KAWASUMI LABORATORIES K-CUFF
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Datascope Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool | Dec 26, 2019 | Substantially Equivalent |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump | May 31, 2018 | Substantially Equivalent |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump | Oct 12, 2017 | Substantially Equivalent |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case | Jan 31, 2017 | Substantially Equivalent |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Jul 2, 2015 | Substantially Equivalent |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | Dec 12, 2013 | Substantially Equivalent |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | Sep 25, 2007 | Substantially Equivalent |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | Feb 14, 2007 | Substantially Equivalent |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | Feb 5, 2007 | Substantially Equivalent |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | Jan 5, 2007 | Substantially Equivalent |