GAS COLLHCTOR BE 155(155-2-3,154-4)
FDA 510(k) clearance K770632 · decided 1977-04-08
Clearance details
- K-number
- K770632
- Device name
- GAS COLLHCTOR BE 155(155-2-3,154-4)
- Applicant
- Instrumentation Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-04
- Decision date
- 1977-04-08
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- KGK
- Device class
- 1
- Regulation number
- 868.1575
- 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 |
|---|---|---|
| RESPIRONICS PROTECTEASY (K863171) | Respironics, Inc. | 1986-10-15 |
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 |