FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDILAC #SR4 & SR 40
K Number: K820256
·
Decision Jun 25, 1982
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
11
Review Days
147
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Basic Information
- Device Name
- MEDILAC #SR4 & SR 40
- K Number
- K820256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spelna, Inc.
- Date Received
- January 29, 1982
- Decision Date
- June 25, 1982
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Spelna, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852525 | SATALEC PIEZOTEC | Jan 30, 1986 | Substantially Equivalent |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | Jan 3, 1986 | Substantially Equivalent |
| K852522 | SATALEC SERVOTOME | Dec 27, 1985 | Substantially Equivalent |
| K853200 | 5X2 SATALEC CHIROPODY CASE | Oct 18, 1985 | Substantially Equivalent |
| K852524 | SATALEC SERVOTORQUE S2 SX2 | Jul 31, 1985 | Substantially Equivalent |
| K852521 | SATLEC PROPHY UNIT PU 3055 | Jul 31, 1985 | Substantially Equivalent |
| K832674 | SATELEC PROPHY UNIT PU 2000S | Mar 16, 1984 | Substantially Equivalent |
| K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | Mar 16, 1984 | Substantially Equivalent |
| K832673 | SATELEC PROPHY UNIT PU-2000 | Oct 19, 1983 | Substantially Equivalent |
| K832665 | SATELEC SUPRASSON SP 3055 | Oct 19, 1983 | Substantially Equivalent |