Submission Details
| 510(k) Number | K963005 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 1996 |
| Decision Date | August 23, 1996 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
Aug 1996
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K963005 is an FDA 510(k) clearance for the NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE), a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on August 23, 1996, 21 days after receiving the submission on August 2, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.
Device Classification
| Product Code | JFL — Ph Rate Measurement, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
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