Atlas FDA

BRUSHRITE

FDA 510(k) clearance K880442 · decided 1988-05-16

Clearance details

K-number
K880442
Device name
BRUSHRITE
Applicant
Pro Care Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1988-02-02
Decision date
1988-05-16
Days to decision
104 days
Clearance type
Traditional
Product code
JEG
Device class
2
Regulation number
868.1075
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
West Point, NE, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Pro Care Laboratories

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

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.

Recalls involving this device

No recalls on record reference this clearance.