MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
FDA 510(k) clearance K854581 · decided 1986-02-28
Clearance details
- K-number
- K854581
- Device name
- MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
- Applicant
- Machida America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-15
- Decision date
- 1986-02-28
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Machida America
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.