KELLER PULSE OXIMETER, MODEL 850+
FDA 510(k) clearance K982331 · decided 1998-09-11
Clearance details
- K-number
- K982331
- Device name
- KELLER PULSE OXIMETER, MODEL 850+
- Applicant
- Keller Medical Specialties Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-02
- Decision date
- 1998-09-11
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Antioch, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Keller Medical Specialties Products
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.
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.