MODEL IRC PASSPORT NEBULIZER
FDA 510(k) clearance K914251 · decided 1992-01-24
Clearance details
- K-number
- K914251
- Device name
- MODEL IRC PASSPORT NEBULIZER
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-23
- Decision date
- 1992-01-24
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- LAW
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Elyria, OH, 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 |
|---|---|---|
| CHEM CHEX THEOPHYLLINE CONTROL (K920223) | Streck Laboratories, Inc. | 1992-06-10 |
| BIOTRACK THEOPHYLLINE QUALITY CONTROLS (K903924) | Biotrack, Inc. | 1990-09-17 |
| THEOPHYLLINE FPIA CONTROLS (K871589) | Sigma Chemical Co. | 1987-06-17 |
Recalls involving this device
No recalls on record reference this clearance.