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FDA 510(k)

PM-3

K-Number: K831750 · 1983-07-26

ApplicantDelta Medical Industries
Decision Date1983-07-26
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PM-3 is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Industries. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831750. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PM-3?

PM-3 is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Delta Medical Industries. The 510(k) number is K831750.

When did PM-3 receive FDA 510(k) clearance?

PM-3 received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831750.

Who is the listed applicant for PM-3?

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

What is the FDA product code for PM-3?

The FDA product code for PM-3 is DXS.

Other records listing Delta Medical Industries 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.

K833884ISOTEC DISPOS. PRESSURE TRANSDUCERK840253ONE-WAY AIR VALVEK832470INFUSION PUMPK830389ACCU-RYNGE PUMP SP-250K822761DELIVERY TUBE SET #2226K820912PMS-2 PRESSURE MONITOR SEPARATOR

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Related Devices (Code: DXS)

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.

K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology IncorporatedK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.K873802PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, 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.

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