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FDA 510(k)

3P (PULMONARY PERCUSSIVE PACK)

K-Number: K931988 · 1994-10-28

Decision Date1994-10-28
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

3P (PULMONARY PERCUSSIVE PACK) is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Manuf, Inc.. It received FDA 510(k) clearance on 1994-10-28 under 510(k) number K931988. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3P (PULMONARY PERCUSSIVE PACK)?

3P (PULMONARY PERCUSSIVE PACK) is a medical device that received FDA 510(k) clearance on 1994-10-28. The listed applicant is Delta Medical Manuf, Inc.. The 510(k) number is K931988.

When did 3P (PULMONARY PERCUSSIVE PACK) receive FDA 510(k) clearance?

3P (PULMONARY PERCUSSIVE PACK) received FDA 510(k) clearance on 1994-10-28, under 510(k) number K931988.

Who is the listed applicant for 3P (PULMONARY PERCUSSIVE PACK)?

The FDA 510(k) record lists Delta Medical Manuf, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3P (PULMONARY PERCUSSIVE PACK)?

The FDA product code for 3P (PULMONARY PERCUSSIVE PACK) is BYI.

Related Clinical Trials

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.

Related Devices (Code: BYI)

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.

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.

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