Antistatic Compact Space Chamber
FDA 510(k) clearance K143615 · decided 2016-01-26
Clearance details
- K-number
- K143615
- Device name
- Antistatic Compact Space Chamber
- Applicant
- Medical Developments International Limited
- Decision
- Substantially Equivalent
- Date received
- 2014-12-19
- Decision date
- 2016-01-26
- Days to decision
- 403 days
- Clearance type
- Traditional
- Product code
- NVP
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Springvale, AU
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Developments International Limited
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.