FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K Number: K896030
·
Decision Dec 22, 1989
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
230
Review Days
66
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
- HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
- K Number
- K896030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hewlett-Packard Co.
- Date Received
- October 17, 1989
- Decision Date
- December 22, 1989
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CCK), ordered by most recent decision date.
Capnostream35 Portable Respiratory Monitor (PM35MN)
FDA 510(k)
FDA Class 2
·Anesthesiology
Medical Gas Analyzer (AG200)
FDA 510(k)
FDA Class 2
·Anesthesiology
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
FDA 510(k)
FDA Class 2
·Anesthesiology
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
FDA 510(k)
FDA Class 2
·Anesthesiology
AIM (N/A)
FDA 510(k)
FDA Class 2
·Anesthesiology
AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Hewlett-Packard Co.
| K Number | Device Name | ||
|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | May 18, 2000 | Substantially Equivalent |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Jan 20, 2000 | Substantially Equivalent |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | Dec 20, 1999 | Substantially Equivalent |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | Dec 1, 1999 | Substantially Equivalent |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | Oct 21, 1999 | Substantially Equivalent |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Aug 31, 1999 | Substantially Equivalent |
| K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A | Aug 5, 1999 | Substantially Equivalent |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Feb 24, 1999 | Substantially Equivalent |