FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDIOVIT AT-1C, AT-2C
K Number: K953396
·
Decision Dec 19, 1995
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
10
Review Days
152
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Basic Information
- Device Name
- CARDIOVIT AT-1C, AT-2C
- K Number
- K953396
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schiller America, Inc.
- Date Received
- July 20, 1995
- Decision Date
- December 19, 1995
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Schiller America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973735 | MICROVIT MT-100 | Aug 25, 1998 | Substantially Equivalent |
| K973751 | MT-200 | Aug 25, 1998 | Substantially Equivalent |
| K970879 | CARDIOVIT CS-200 | Jun 25, 1997 | 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 |