HAYMAX
FDA 510(k) clearance K120894 · decided 2012-05-17
Clearance details
- K-number
- K120894
- Device name
- HAYMAX
- Applicant
- Haymax Limited
- Decision
- Substantially Equivalent
- Date received
- 2012-03-23
- Decision date
- 2012-05-17
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- NUP
- Device class
- 2
- Regulation number
- 880.5045
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ampthill, Bedfordshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.