SPIROMETER ISOLATION VALVE #8890
FDA 510(k) clearance K833088 · decided 1983-10-28
Clearance details
- K-number
- K833088
- Device name
- SPIROMETER ISOLATION VALVE #8890
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-12
- Decision date
- 1983-10-28
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- CAI
- Device class
- 1
- Regulation number
- 868.5240
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| CONDENSATE COLLECTION KIT (K954480) | Nova-Ventrx | 1995-12-29 |
| UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787) | Unicor, Inc. | 1995-09-19 |
| PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014) | Prima, Inc. | 1995-05-22 |
| PRIMA ADULT GAS SAMPLING CIRCUITS (K952019) | Prima, Inc. | 1995-05-22 |
| PRIMA COAXIAL CIRCUITS (K952018) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016) | Prima, Inc. | 1995-05-22 |
| PRIMA MAPLESON D CIRCUIT (K952017) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009) | Prima, Inc. | 1995-05-19 |
| SPIRO-FLEX (K945565) | Inhalation Plastics | 1995-01-13 |
| NEONATAL BREATHING CIRCUIT MODIFICATION (K932288) | Simplex Medical Systems, Inc. | 1994-12-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |