CLAMP BE-152
FDA 510(k) clearance K770628 · decided 1977-05-23
Clearance details
- K-number
- K770628
- Device name
- CLAMP BE-152
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-04
- Decision date
- 1977-05-23
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JAY
- Device class
- 1
- Regulation number
- 868.5280
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CUSTOM MEDICAL SUSPENSION STRAP (K944988) | Custom Medical Specialties, Inc. | 1995-01-27 |
| BLOCK, BITE, INTUBATION (K873491) | B&B Medical Technologies, Inc. | 1987-10-20 |
| DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (K860583) | Dale Medical Products, Inc. | 1986-02-21 |
| JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (K850924) | Vulcan Laboratories, Inc. | 1985-07-19 |
| COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (K850309) | Ackrad Laboratories | 1985-02-14 |
| ENDO-SECURE (K840844) | Exidyne, Inc. | 1984-03-16 |
| TRACH MATE (K834265) | Tempe Biomedical, Inc. | 1984-01-04 |
| COMFIT (K834089) | Ackrad Laboratories | 1983-12-29 |
| TUBE-TITLE (K833361) | Sontek Industries, Inc. | 1983-11-03 |
| BITE-BLOCK (K833374) | Sontek Industries, Inc. | 1983-11-03 |
| SCHULTZ ENDHOLD (K833332) | Polyclinic Medical Center | 1983-10-31 |
| DALE ENDOTRACHEAL TUBE HOLDER (K832946) | Dale Medical Products, Inc. | 1983-10-14 |
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 |