0.9% SODIUM CHLORIDE SOL./RESP. THERAPY

FDA 510(k) clearance K800295 · decided 1980-03-10

Clearance details

K-number

K800295

Device name

0.9% SODIUM CHLORIDE SOL./RESP. THERAPY

Applicant

Abbott Laboratories

Decision

Substantially Equivalent

Date received

1980-02-11

Decision date

1980-03-10

Days to decision

28 days

Clearance type

Traditional

Product code

CAF

Device class

2

Regulation number

868.5630

Medical specialty

Anesthesiology

Advisory committee

Anesthesiology

Location

Abbott Park, IL, US

Third-party review

No

Expedited review

No

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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.

PMA approvals by this applicant