OHMEDA 5330 AGENT MONITOR
FDA 510(k) clearance K890606 · decided 1989-04-20
Clearance details
- K-number
- K890606
- Device name
- OHMEDA 5330 AGENT MONITOR
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1989-02-06
- Decision date
- 1989-04-20
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- CBQ
- Device class
- 2
- Regulation number
- 868.1500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Englewood, CO, 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 |
|---|---|---|
| PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (K040917) | Philips Medizin Systeme Boeblingen GmbH | 2004-04-29 |
| MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (K994188) | Agilent Technologies, GmbH | 2000-05-19 |
| OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (K962648) | Ohmeda Medical | 1997-01-17 |
| OHMEDA MODEL 5330 ANESTHETIC MONITOR (K931439) | Ohmeda Medical | 1993-10-19 |
| DATASCOPE MULTINEX II (K926451) | Datascope Corp. | 1993-08-25 |
| AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (K923433) | Instrumentarium Corp. | 1993-07-22 |
| CAPNOMAC ULTIMA ANESTHESIA MONITOR (K923276) | Datex Division Instrumentarium Corp. | 1993-07-21 |
| AS/3 COP MODULE (K922876) | Datex Division Instrumentarium Corp. | 1993-07-21 |
| DATASCOPE MULTINEX ID PLUS (K930303) | Datascope Corp. | 1993-06-16 |
| ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (K914295) | Bruel & Kjaer | 1992-04-10 |
| NGM FRAME (K911644) | Datex Division Instrumentarium Corp. | 1992-03-04 |
| NGM GAS MODULE (K911647) | Datex Division Instrumentarium Corp. | 1991-09-19 |
Recalls involving this device
No recalls on record reference this clearance.