FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 78850 OXYGEN MONITOR
K Number: K812167
·
Decision Aug 31, 1981
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
230
Review Days
32
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
- MODEL 78850 OXYGEN MONITOR
- K Number
- K812167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hewlett-Packard Co.
- Date Received
- July 30, 1981
- Decision Date
- August 31, 1981
- Product Code
- KLK
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLK), ordered by most recent decision date.
MICROGAS 7650 TRANSCUTANEOUS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROGAS 7650 TRANSCUTANEOUS MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
FDA 510(k)
FDA Class 2
·Anesthesiology
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
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 |