ATLANTIS HYPERBARIC CHAMBER VENTILATOR
FDA 510(k) clearance K092264 · decided 2009-12-17
Clearance details
- K-number
- K092264
- Device name
- ATLANTIS HYPERBARIC CHAMBER VENTILATOR
- Applicant
- Providence Global Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-28
- Decision date
- 2009-12-17
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Providence Global Medical
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.
Recalls involving this device
No recalls on record reference this clearance.