FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROVIT MT-100
K Number: K973735
·
Decision Aug 25, 1998
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
10
Review Days
329
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Basic Information
- Device Name
- MICROVIT MT-100
- K Number
- K973735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schiller America, Inc.
- Date Received
- September 30, 1997
- Decision Date
- August 25, 1998
- 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 Schiller America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973751 | MT-200 | Aug 25, 1998 | Substantially Equivalent |
| K970879 | CARDIOVIT CS-200 | Jun 25, 1997 | Substantially Equivalent |
| K953396 | CARDIOVIT AT-1C, AT-2C | Dec 19, 1995 | Substantially Equivalent |
| K954066 | MINISCOPE MS-3 | Oct 27, 1995 | Substantially Equivalent |
| K941462 | CARDIOVIT AT-5C | May 19, 1995 | Substantially Equivalent |
| K946205 | CARDIOVIT AT-1, P-80 | Mar 16, 1995 | Substantially Equivalent |
| K914970 | CARDIOVIT CS-100 | Nov 3, 1992 | Substantially Equivalent |
| K896121 | SCHILLER MODEL SP-200 SPIROVIT(TM) | Jan 9, 1990 | Substantially Equivalent |
| K896120 | SCHILLER MODEL SP-100 SPIROVIT(TM) | Jan 9, 1990 | Substantially Equivalent |