Atlas FDA

CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO

FDA 510(k) clearance K982487 · decided 1998-10-14

Clearance details

K-number
K982487
Device name
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
Applicant
Cardiopulmonary Technologies, Inc.
Decision
Substantially Equivalent
Date received
1998-07-17
Decision date
1998-10-14
Days to decision
89 days
Clearance type
Traditional
Product code
BZC
Device class
2
Regulation number
868.1880
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Colgate, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.