NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
FDA 510(k) clearance K904499 · decided 1991-07-01
Clearance details
- K-number
- K904499
- Device name
- NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
- Applicant
- Ackrad Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-10-01
- Decision date
- 1991-07-01
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- KFG
- Device class
- 1
- Regulation number
- 866.3040
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cranford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ASPERGILLUS SP, ANTISERUM POSITIVE (K792686) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ASPERGILLUS SP, ANTISERUM, POSITIVE (K792698) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM (K791386) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) (K760835) | I M, Inc. | 1976-11-01 |
Recalls involving this device
No recalls on record reference this clearance.