SYRINGE 500BC BE #7000
FDA 510(k) clearance K830898 · decided 1983-05-16
Clearance details
- K-number
- K830898
- Device name
- SYRINGE 500BC BE #7000
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-21
- Decision date
- 1983-05-16
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- BXW
- Device class
- 1
- Regulation number
- 868.1870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Instrumentation Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (K853848) | Medical Graphics Corp. | 1985-12-05 |
| FLOW-CALIBRATION MODULE (K831758) | The Perkin-Elmer Corp. | 1983-07-19 |
| DATASCRIBE #DS-40 (K812765) | Timeter Instrument Corp. | 1981-11-16 |
| OHIO CAL-CHEK (K810290) | Ohio Medical Products | 1981-02-12 |
| CALIPERS, MCGAW SKINFOLD (K760520) | Mcgaw Laboratories | 1976-11-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE CHANGERS (P800068/S002) | Instrumentation Industries, Inc. | 1999-11-04 |
| ENDOTRACHEAL TUBE CHANGER (P800068/S001) | Instrumentation Industries, Inc. | 1999-07-23 |
| ENDOTRACHEAL TUBE CHANGER (P800068) | Instrumentation Industries, Inc. | 1981-07-21 |