FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K Number: K820135
·
Decision Mar 1, 1982
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
37
Review Days
42
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Basic Information
- Device Name
- TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
- K Number
- K820135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- January 18, 1982
- Decision Date
- March 1, 1982
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
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| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | Jul 18, 1984 | Substantially Equivalent |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Jul 13, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |