Atlas FDA

PNEUMOSCOPE

FDA 510(k) clearance K852337 · decided 1985-07-01

Clearance details

K-number
K852337
Device name
PNEUMOSCOPE
Applicant
Erich Jaeger, Inc.
Decision
Substantially Equivalent
Date received
1985-05-31
Decision date
1985-07-01
Days to decision
31 days
Clearance type
Traditional
Product code
BZG
Device class
2
Regulation number
868.1840
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Rockford, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Erich Jaeger

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.

RecordFirmDate
MESI mTABLET SPIRO (K251777)Mesi D.O.O.2026-03-02
TD-7301 Spirometer (TD-7301) (K241843)Gostar Co., Ltd.2024-11-20
Air Next (NVD-02) (K231416)Nuvoair AB2024-01-18
Spirobank Oxi (K230501)Mir Medical International Research USA2023-12-15
EasyOne Sky Spirometer (K230178)Ndd Medizintechnik AG2023-10-19
Alveoair Digital Spirometer (K222525)Roundworks Technologies Private Limited2023-08-28
Air Smart Extra Spirometer (K222443)Feellife Health, Inc.2023-08-09
SpiroHome Personal, SpiroHome Clinic (K213754)Inofab Saglik Teknolojileri A.S2023-06-12
ComPAS2 (K213872)Morgan Scientific, Inc.2022-07-15
Vitalograph Model 6000 Alpha (K212938)Vitalograph Ireland, Ltd.2022-01-26
Spirometer (K201493)Mehow Innovative, Ltd.2021-06-10
GoSpiro (K202837)Monitored Therapeutics, Inc.2020-12-04

Recalls involving this device

No recalls on record reference this clearance.