Question 1

Who is the manufacturer of LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000?

Accepted Answer

Rustronics, Inc. filed the 510(k) submission for LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 (K930549).

Question 2

What is the FDA product code for LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000?

Accepted Answer

BTA. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000 cleared by the FDA?

Accepted Answer

Jun 18, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K930549
Device Name	LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000
Applicant	Rustronics, Inc.
Product Code	BTA · General, Plastic Surgery
Decision Date	Jun 18, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2

LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000

Device Facts

Regulatory Classification

Identification