HUMID-VENT(R) MINI
FDA 510(k) clearance K873767 · decided 1987-11-06
Clearance details
- K-number
- K873767
- Device name
- HUMID-VENT(R) MINI
- Applicant
- Gibeck Respiration
- Decision
- Substantially Equivalent
- Date received
- 1987-09-16
- Decision date
- 1987-11-06
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- BYD
- Device class
- 1
- Regulation number
- 868.5375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Schaumburg, 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 |
|---|---|---|
| HEAT & MOISTURE EXCHANGER (K955008) | Intertech Resources, Inc. | 1996-01-30 |
| DISPOSABLE HME/FILTER (K954194) | Engstrom Medical | 1995-10-20 |
| HEAT MOISTURE EXCHANGER (K953580) | Intertech Resources, Inc. | 1995-09-15 |
| TYPE 1 & 2 (HUMIDAIR I & II) (K953507) | Icor AB | 1995-09-07 |
| HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (K953544) | Gibeck, Inc. | 1995-08-25 |
| HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (K953491) | Gibeck, Inc. | 1995-08-25 |
| WARM N WET HMEF W/LUER ADAPTER (K953620) | Hospitak, Inc. | 1995-08-25 |
| EEE (K953540) | Edentec Corp. | 1995-08-25 |
| WARM N WET HME W/LUER ADAPTER (K953619) | Hospitak, Inc. | 1995-08-25 |
| HUMID-VENT TRACH-VENT (K952845) | Gibeck, Inc. | 1995-07-25 |
| HUMID-VENT 2 (K952844) | Gibeck, Inc. | 1995-07-20 |
| HUMID-VENT 1 (K952750) | Gibeck, Inc. | 1995-07-20 |
Recalls involving this device
No recalls on record reference this clearance.