LIFESPAN(TM) 100 TCPCO2 MONITOR
FDA premarket approval P820019/S006 · decided 1986-01-27
Approval details
- PMA number
- P820019
- Supplement
- S006
- Trade name
- LIFESPAN(TM) 100 TCPCO2 MONITOR
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Biochem International, Inc.
- Date received
- 1985-02-15
- Decision date
- 1986-01-27
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Waukesha, WI
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOCHEM MODEL 3302 NEWOX2 OXIMETER (K920083) | Biochem International, Inc. | 1994-04-11 |
| 8100 ANESTHETIC AGENT MONITOR (K932389) | Biochem International, Inc. | 1993-12-03 |
| BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE (K921388) | Biochem International, Inc. | 1993-05-26 |
| BIOCHEM MODEL 3301 NEWOX1 OXIMETER (K920082) | Biochem International, Inc. | 1993-01-07 |
| BIOCHEM TEMPERATURE/ FIO2 MODULE (K910381) | Biochem International, Inc. | 1991-08-22 |
| BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP (K911351) | Biochem International, Inc. | 1991-08-22 |
| BIOCHEM 6100 NON-INVASIVE MONITOR (K903222) | Biochem International, Inc. | 1990-09-04 |
| BIOCHEM 9100 MULTIGAS MONITOR (K901861) | Biochem International, Inc. | 1990-07-27 |