Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007127387

FEI Number

3007127387

Entity Name

HYPERBARIC S.A.C.

City/State/Country

Lima Lima (Region), PE

Establishment Address

AV. PEDRO HUILCA MZ. C, LOTE 9, Parque Ind PARQUE INDUSTRIAL, PARC II, VILLA EL SALVADOR, Lima Lima (Region) 15816, PE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hyperbaric S.A.C. (Owner Number: 10026695)

Owner / Operator Contact Address

AV. PEDRO HUILCA MZ. C, LOTE 9, PARQUE INDUSTRIAL, PARC II, VILLA EL SALVADOR, PE-LMA 15816, PE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081506

PMA Number

N/A

All Registered Proprietary Names

OXICAB ML-4BZ-18 OXICAB ML-60 OXICAB MO-13

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBF	Chamber, Hyperbaric	Anesthesiology	Class 2	868.5470	2008-08-12

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

Hyperbaric S.A.C.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007127387. Last updated year: 2026. Please use registration number 3007127387 when referencing this establishment in official correspondence.