510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JAXClass II

Pneumotachometer

21 CFR 868.2550 / Anesthesiology
FDA source (opens on fda.gov)

JAX is the FDA product code for Pneumotachometer, a class II device type, regulated under 21 CFR 868.2550. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JAX
Device name
Pneumotachometer
Regulation
21 CFR 868.2550
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code JAX

By decision year
8 clearances under product code JAX with a decision year between 1977 and 2000, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JAX by decision year
YearClearances
19771
19791
19811
19831
19851
19891
19921
20001

Applicants with the most clearances

Product code JAX
Applicants holding the most 510(k) clearances under product code JAX
ApplicantClearances
Research Development Corp.2
Biotrine Corp.1
Medical Associated Services, Inc.1
Peace Medical, Inc.1
Sdi Diagnostics, Inc.1
Spirometrics, Inc.1
Thoratec Laboratories Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code