FDA 510(k)

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter

K-Number: K233553 · 2024-06-18

Decision Date2024-06-18

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Thayer Medical Corporation. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233553. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Thayer Medical Corporation. The 510(k) number is K233553.

When did MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter receive FDA 510(k) clearance?

MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233553.

Who is the listed applicant for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

The FDA 510(k) record lists Thayer Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter?

The FDA product code for MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter is CAF.

Other records listing Thayer Medical Corporation 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.

K210558LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber K160109Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber

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Official Source

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