Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAMM-AIRE CP

K-Number: K893681 · 1989-07-20

ApplicantCustom Medical Products, Ltd.
Decision Date1989-07-20
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMM-AIRE CP is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1989-07-20 under 510(k) number K893681. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMM-AIRE CP?

MAMM-AIRE CP is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Custom Medical Products, Ltd.. The 510(k) number is K893681.

When did MAMM-AIRE CP receive FDA 510(k) clearance?

MAMM-AIRE CP received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893681.

Who is the listed applicant for MAMM-AIRE CP?

The FDA 510(k) record lists Custom Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMM-AIRE CP?

The FDA product code for MAMM-AIRE CP is IZO.

Other records listing Custom Medical Products, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K931417STERILE EQUIPMENT COVERSK931456SURGICAL DRAPE AND GOWN TRAYK930815ABDOMINAL / THORACIC PATIENT DRAPEK931418SURGICAL DRAPEK931455HEAD SHEETK931844CUSTOM PROCEDURE MEDICAL TRAY OR KIT

View all 13 devices →

Related Devices (Code: IZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑