FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERCI
K Number: K780838
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
6
Review Days
56
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Basic Information
- Device Name
- PERCI
- K Number
- K780838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Micro Tronics Corp.
- Date Received
- May 22, 1978
- Decision Date
- July 17, 1978
- Product Code
- BXX
- 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 |
|---|---|---|---|
| BXX | Calibrator, Pressure, Gas | FDA class 1 | Anesthesiology |
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Other Clearances by Micro Tronics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K901797 | THE WONDER BOX | Feb 7, 1991 | Substantially Equivalent |
| K890513 | SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) | Apr 28, 1989 | Substantially Equivalent |
| K863124 | MODEL 8 EEG PREAMPLIFIER | Nov 18, 1986 | Substantially Equivalent |
| K862527 | SLEEP ANALYZING COMPUTER | Oct 6, 1986 | Substantially Equivalent |
| K772005 | MYOTONE EMG MONITOR | Nov 23, 1977 | Substantially Equivalent |