MASK, PXYGEN
FDA 510(k) clearance K781413 · decided 1978-09-07
Clearance details
- K-number
- K781413
- Device name
- MASK, PXYGEN
- Applicant
- Vitalab Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-15
- Decision date
- 1978-09-07
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vitalab Products Corp.
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.