BOTTLE, CONDENSATE (#1628)
FDA 510(k) clearance K760082 · decided 1976-07-16
Clearance details
- K-number
- K760082
- Device name
- BOTTLE, CONDENSATE (#1628)
- Applicant
- Inspiron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-21
- Decision date
- 1976-07-16
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- CBC
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BIRD 1000 PV PORTABLE VENTILATOR (K925422) | Bird Products Corp. | 1993-05-13 |
| AMBU SUCTION BOOSTER (K790035) | Narco Air-Shields | 1979-03-23 |
Recalls involving this device
No recalls on record reference this clearance.