FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, PATIENT, MODEL PM-20N
K Number: K770736
·
Decision Jun 2, 1977
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
186
Applicant Total
32
Review Days
42
Basic Information
- Device Name
- MONITOR, PATIENT, MODEL PM-20N
- K Number
- K770736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CAVITRON CORP.
- Date Received
- April 21, 1977
- Decision Date
- June 2, 1977
- Product Code
- CHL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K802928 | SPIROMETRIC COMPUTER #SC-10 | Dec 17, 1980 | Substantially Equivalent |
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| K801877 | SLIT LAMP ATTACHMENT | Sep 16, 1980 | Substantially Equivalent |
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| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | Apr 29, 1980 | Substantially Equivalent |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Sep 19, 1979 | Substantially Equivalent |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent |
| K782054 | LASER, CO2 SURGICAL | Jan 17, 1979 | Substantially Equivalent |