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FDA 510(k)

RESCUE PACK

K-Number: K830374 · 1983-05-13

ApplicantAkla, Inc.
Decision Date1983-05-13
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESCUE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Akla, Inc.. It received FDA 510(k) clearance on 1983-05-13 under 510(k) number K830374. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESCUE PACK?

RESCUE PACK is a medical device that received FDA 510(k) clearance on 1983-05-13. The listed applicant is Akla, Inc.. The 510(k) number is K830374.

When did RESCUE PACK receive FDA 510(k) clearance?

RESCUE PACK received FDA 510(k) clearance on 1983-05-13, under 510(k) number K830374.

Who is the listed applicant for RESCUE PACK?

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

What is the FDA product code for RESCUE PACK?

The FDA product code for RESCUE PACK is KDD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Akla, Inc. 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.

K830375FIRST AID BAGS #1,2,3K830373FIRST AID KIT

Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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